Manager, Regulatory Resume Samples

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L Hickle

Lucie

Hickle

5927 Trisha Flat

Philadelphia

+1 (555) 283 5249

5927 Trisha Flat

Philadelphia

Phone

p +1 (555) 283 5249

Experience Experience

Dallas, TX

Regulatory Product Manager

Dallas, TX

Bauch Inc

Dallas, TX

Regulatory Product Manager

Ensure that regulatory input is provided into development programs and reports for consistency and fitness for the purpose
Working knowledge of a broad range of scientific disciplines (including biology, toxicology, environmental chemistry, etc.)
Monitor and manage cost recovery programme
Plan and manage global regulatory readiness campaign
Regulatory research and management of regulatory collateral
Develop and maintain high quality relationships with internal and external customers, including regulatory authorities and key influencers
Prepare and submit regulatory package/ supporting documents to ensure registrations are achieved, defended and maintained according to plan

Houston, TX

Regulatory Developments Manager

Houston, TX

Koepp-Connelly

Houston, TX

Regulatory Developments Manager

Heavy emphasis on MiFID II Regulation such as interpreting regulations and drafting policy
Liaising with local teams in global jurisdictions with regards to regulatory change
Ad hoc projects
Other reg knowledge can include - EMIR, AiFMD or SMR
Identify emerging UK and EU regulatory developments
Assess the impact of emerging UK and EU regulatory developments on the business
Ensure emerging UK and EU regulatory developments are communicated to the business including both the Compliance and Risk teams

present

Dallas, TX

Manager, Regulatory Reconciliation

Dallas, TX

Satterfield, Lubowitz and Yundt

present

Dallas, TX

Manager, Regulatory Reconciliation

present

Prepares and communicates recommendations for strengthening controls and assists management in developing action plans to address control weaknesses
Uses performance indicators to establish control mechanisms and other improvement initiatives
Establishes objectives and develops processes and procedures to ensure efficient and timely work flow
Provides guidance and input in recommendations for improvements to business processes
Assist Operations with effective and efficient design and execution of control processes
Performs other duties and responsibilities as assigned
Prepares written reports and delivers oral presentations to internal customers and management

Education Education

Bachelor’s Degree in Business

California State University, Northridge

Bachelor’s Degree in Business

Skills Skills

Strong interpersonal skills with the ability to establish credibility and foster excellent working relationships with internal and external stakeholders
Excellent in-depth technical knowledge of the UK Regulatory Regime
Become knowledgeable of Aviva Investors’ businesses
Strong organisational and planning skills
Strong communication skills
Strong critical thinking and problem-solving skills
In-depth technical knowledge of current UK and EU regulatory developments
Good experience of providing advice within an asset management organisation
Excellent influencing/negotiation skills
Very strong written and verbal communicator

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Compliance Manager Regulatory Examinations Resume Examples & Samples

Provide strategic advice, communications and regular updates to management regarding the significant matters being handled, including, but not limited to, the timely escalatation and resolution of potential issues
Communicate extensively (orally and in writing) with regulators
Establish and develop effective relationships with Compliance, Line of Business, Oversight and Controls, Legal and Internal Audit management
Work with Compliance and business personnel to obtain relevant information / documentation to respond to regulatory requests
Prepare business personnel for meetings with regulators
Identify mitigating facts and circumstances (as applicable) to rebut issues identified during the examination or sweep
Prepare substantial written responses to regulatory requests and Examination Reports. These responses typically advocate on behalf of the Firm and require the ability to apply the facts of each matter to the applicable laws and regulations at issue
Communicate with Compliance and business personnel regarding findings, remediation related to findings and regulatory issues
Four-year degree required or equivalent experience
7 or more years securities compliance or related securities experience required
Experience working at a firm or a regulator on regulatory examinations by the SEC, FINRA, and other securities regulators
Excellent interpersonal, organizational and writing skills required
High attention to detail with strong analytical and logical reasoning skills
Knowledge of products and operations, and applicable securities rules and regulations
Product knowledge should include equities, fixed income and derivatives

Manager, Regulatory Programs Resume Examples & Samples

Support the proactive management of internal audits and regulatory reviews, to ensure the Anti-Money Laundering Responsible Officer ("AMLRO") & Senior Executive Team have line of sight to BHPB-owned findings, management responses and audit ratings, prior to final audit reports being issued
Leading/Assisting in the change management requirements identified by the AML Program; this includes conducting a gap analysis, action plan for program delivery, resolution actions to ensure effectiveness and sustainability and facilitating readiness sessions
Providing oversight on audits and regulatory reviews by: participating in start, exit and fieldwork status meetings; leading response process for requests for information as applicable, and; reviewing findings and CAMLO responses prior to submission to audit or regulator
Building effective working relationships with key stakeholders including BMO’s Internal Audit and Regulatory Risk functions, various AML functions, BHPB lines of business (including Platinum Banking, BMO Harris Investment Management and BMO TrustCo.), and Technology & Operations
Assist in the review and delivery of effective control framework, in addition to monitoring, testing and reporting functions
At least 5 years of banking experience
Project Management – Support project management deliverables
Minimum 3 years of experience in Compliance-related role in financial or securities industry
Minimum Undergraduate degree required
AML/ATF compliance interpretation and advice (as well as other regulatory programs such as CASL, FATCA, QI etc.)
Understanding the risks and associated controls, and the evaluation of AML/ATF risk acceptance or mitigation actions
ACAMS (AML certification considered an asset with intention to complete with designation within 18 months following commencement of role)
Knowledge of BHPB business, products, services and systems
Excellent organizational understanding with regard to PCG Businesses, its processes and services
Excellent environmental understanding with regard to the regulatory environment
Strong risk management skills
Strong influencing and communication skills
Good project and change management skills
Capable of handling multiple tasks and meeting stringent deadlines

Manager, Regulatory Solutions Resume Examples & Samples

FATCA product and related products including 'GATCA': Flowcharting, liaison with in house software developers, testing, technical client queries, technical research based on reading US code, IGAs, local administrative guidance, OECD/EU Commission materialsWork proactively to develop and implement new logical treatments of new interpretations within the regulatory and analytics space
German, UK and US funds tax compliance: High involvement in a material client (until mid 2015), oversight of tax figures, liaison with tax advisors materially German tax advisors
Preparation of FIN48 workings and reports for clients
Responding to general client enquiries on tax matters
VAT return preparation
Chartered Accountant, CPA, Member of Institute of tax or similar
Specialist in tax
Commercial experience whilst working in an asset manager or fund administrator role, or fund administrator in a tax related role
‘Can do’ attitude

Business Project Manager Regulatory Change Resume Examples & Samples

Lead projects and activities related to regulatory change across the FRC business area. This includes making business decisions, producing business requirements, facilitating workshops, project planning, running project meetings and testing delivered solutions
Partner with IT, data, on-boarding, business management and operations to manage and facilitate the full project lifecycle – requirement analysis, design, build, test and implementation
Measure and monitor progress at clearly defined points in the project lifecycle to ensure that projects are delivered on time and meet or exceed expectations. Balance scope, schedule, quality and risks. Make adjustments as necessary. Regularly update sponsors on status of projects at stakeholder steering meetings
Manage relationships and coordinate work between cross functional teams, potentially in different locations
Ensure that the end product fulfils the sponsor's expectations
Ad hoc issue management and resolution

Manager, Regulatory Stress Testing Model Resume Examples & Samples

Familiarity with the mathematical/statistical tools needed for studying heavy-tailed operational loss distributions, event frequency processes, and correlation between event types
Design of econometric models to explore relationships between operational losses and the macroeconomic climate
Perform statistical research and literature reviews to provide insights into industry range of practice and support for various modeling choices
Write and maintain code for performing the above functions
Produce and maintain well-articulated documentation on the above
Aid in preparation of materials for inclusion in memos and presentations for internal senior management and regulators on all quantitative aspects related to AMA models
Work closely with analysts and managers in the operational risk department in both Canada and the U.S
Keep up to date on emerging research in this sector, attend conferences, and make contact with peers at other financial institutions
Perform ad hoc analyses as required by management and other business partners throughout the year
Representing TD as a subject matter expert in meetings with Regulators
Ensure documentation (methodologies, step-by-step procedures) for internal audit and regulatory purposes are complete, accurate and meet all regulatory standards
Conduct periodic evaluations and/or benchmarking of TD’s stress testing methodology and results to industry results and best practices
Ensure the methodology can be leveraged for similar Canadian regulatory stress testing exercises (e.g. Bank of Canada/OSFI; Enterprise-wide Stress Test)

IT Operations Manager Regulatory Applications Resume Examples & Samples

Ensuring application availability, performance and stability – SLAs met
Dashboards & Metrics- reviews & reporting
Ability to provide hands-on technical support as when required
Business Customer management - service management, review & improvement plans
IT Operations management - change, release, incident, problem, knowledge and compliance management
Support Projects/Programs teams with release & deployment and transition to production processes
Drive technical strategies to improve and evolve all aspects of the applications – infrastructure, application, database, network etc
Lead Customer Facing Regulatory applications support teams
Application Maintenance and Support
Compliance management
Defines detailed functional and technical specifications required to satisfy business requirements for programs, projects, and releases
Communicates design, functional, and technical specifications to development team
Provides solution planning and estimating of programs and projects
Bachelor's Degree (or minimum 4 years of equivalent work experience) with minimum 2 years of IT experience Eligibility Requirements
Must be able to satisfy the requirements of Section 19 of the Federal Deposit Insurance Act
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen
Must be willing to work out of an office in Van Buren Township, MI
Oracle and MS SQL databases experience and knowledge
Experience with UNIX/LINUX/Redhat/MS Operating System tools
Infrastructure monitoring tools like HP, Topaz and OEM – proactive vs. reactive, console and event management
Experience of supporting a multiple applications - product releases, staging releases, vendor supplied updates and product patches
Ensuring fixes to code are effectively managed by the technical team
Strong Customer Service Background - Regulatory applications include mission critical applications with key business users demanding high quality solutions and services
Ability to deliver solutions quickly and manage multiple stakeholder expectations
Experience with team leadership, project management, and execution of multiple simultaneous and/or large projects
Experience leading a technical team
Demonstrates command of multiple programming languages, basic systems analysis techniques, testing, debugging, documentation standards, file design, storage, and interfacing
Competent in strategic thinking and leadership #DTR

Manager, Regulatory Assurance Resume Examples & Samples

Assisting with preparation for external and internal regulatory reviews
Conducting special investigations
Identifying efficiencies and driving initiatives to achieve greater compliance and business oriented results
An inquisitive and analytical mind with the ability to proactively identify and analyse problems, and propose viable solutions
The ability to work to deadlines whilst maintaining a high degree of accuracy and quality; handle multiple tasks and prioritise effectively

Senior Project Manager, Regulatory & Control Resume Examples & Samples

Drive project planning including cross functional team leadership to deliver seamless integration of regulatory initiatives
Evaluate client and franchise impacts relating to regulatory environment working with Legal, Compliance, Regulatory Relations, Community Development, Corporate Communications and Client Experience
Partner with communications, disclosure management and training to ensure both consumer and field readiness relating to regulatory change
Oversee technology requirements associated with planned regulatory initiatives, including appropriate test planning and seamless delivery
Lead select regulatory exam management efforts for deposit product team
Support Management Control Assessment and Product Policy function for the Banking Products team, including oversight and adherence to established product policies and quarterly management reporting
Demonstrated ability to drive large scale projects and cross functional teams
Influence management
Ability to work in a matrixed organization

Manager Regulatory Capital Derivatives & Sft Resume Examples & Samples

Plan and report quarterly Basel III regulatory reporting and focus on delivery timelines are met; issues are resolved
Develop and maintain a good relationship with all the stakeholders (GBM, Market Risk, APP, ect)
Involve in new model developments that have capital impact and coordinate with risk managements
Recommend to Senior Manager improvement opportunities in existing methodology and process
Support the managers & team with in-depth analysis for systems changes and banks' readiness to comply with any new rules
Develop and maintain derivatives and SFT expertise in Basel III reporting and cross-train other groups which provide support (IT&S, Market Risk)
This incumbent will provide extensive support for blue book reporting, including verify, check and review the blue book
Work on Banks’s participation of QIS studies as initiated by BIS consultative documents, concentrating on derivative portfolio
Work with External and Internal auditors to ensure that all Financial Statement and Pillar 3 disclosures are published meeting SOX requirements
Work with GRM and Market risk group to monitor the market risk on regular basis and report any adverse regulatory capital impact from the Bank’s trading book exposure
Strong knowledge of Derivative Portfolios and SFT, including product knowledge, related accounting, valuation, settlements, and netting
Strong communication skill
Good experience in process automation and reconciliations

Senior Audit Manager Regulatory Reform Resume Examples & Samples

8+ years of related experience in a Senior-level position
Working knowledge of Regulatory Reform, including Dodd Frank regulations and industry requirements
Previous experience with Audit (Operational) and Internal Controls

Manager, Regulatory & Audit Compliance Resume Examples & Samples

Undergraduate degree in related discipline (business or finance) required
Minimum 5 years business experience at a financial institution preferably in a regulatory, compliance, audit and/or risk management role
Strong understanding of linkage between Consumer Risk strategies, the Canadian regulatory environment and standard audit requirements
Working knowledge of the Basel II framework and OSFI regulatory requirements
Through knowledge of BMO’s organization and interrelationships and working knowledge of Consumer line of business (preferred but not essential)
Strong interpersonal and communications skills and demonstrated ability to collaborate, influence and consult
Some project management experience and ability to multi-task would be an asset to manage concurrent priorities
Strong analytical skills and ability to synthesize complex regulatory communications in to manageable / actionable insights and instructions
Comfortable working in a moderate to high-stress environment

Manager Regulatory for Financial Services Resume Examples & Samples

You liaise with people from our Tax department, other EY offices, clients, lawyers, notaries, banks, asset managers, etc
You advise on and coordinate the set-up of Luxembourg bank subsidiaries or branches and of PSFs including payment institutions, EMIs, etc
You structure and list debt and equity securities issues (standalone issues and issuance programs) which includes drafting of all documents in view of listing and liaise with service providers, ICSDs, LuxSE and/ or CSSF
You ensure high quality delivery of general advice on regulatory matters for banks (incl. Basel III, CRD IV, MiFID, Solvency II etc.) and capital markets (incl. Prospectus Directive, Transparency Directive, LuxSE internal rules etc.) for our clients
You share your excellent know-how and knowledge of bank/ capital markets regulatory matters with your department
You seize new business opportunities and participate proactively to the definition of new solutions/ service offerings in the bank/ capital markets sector
You collaborate on large set-up engagements with operational and IT consultants
You will be in charge of coaching/ mentoring a pool of junior professionals, which includes delegating and monitoring work, ensuring high quality deliverables, monitoring budget and deadlines

Regulatory Content Manager, VP Resume Examples & Samples

Knowledge of Information Security, Corporate Risks, IT Controls and Regulations
Proficient in MS Office (Word, Excel, Access, and Power Point) and SharePoint
Ability to provide concise materials whilst addressing the regulatory request for information
Ability to deliver high quality results under tight deadlines
Role requires a candidate with a strong analytical background and technical skills

Regulatory Team Manager Resume Examples & Samples

BS/MS/PHD in related discipline of biology, ecology, or environmental science
Minimum of 10+ demonstrated years of experience in field
Minimum of 3+ years of experience managing or leading staff in biological or regulatory projects
Experience completing permits under the Clean Water Act (e.g., CWA Section 401, 404, including preparation of 404(b)(1) Alternatives Analysis)
Demonstrated ability to manage permit application processes from start to finish
Experience with business development and client development
Knowledge of Programmatic Permitting Options with each Agency
Individual and Master Lake or Streambed Alteration Agreements
Waters and Wetlands Compensatory Mitigation Planning
Waters and Wetlands Jurisdictional Determinations
Impact Analysis and Alternatives Analysis
Section 7 and 10 Endangered Species Act Consultations
Competitive Proposal Writing
Demonstrated Business Development Capabilities
Public Speaking/Presenting Capabilities
California Rapid Assessment Method (CRAM) trained and experience using the Corps’ Mitigation Ratio Checklist
Strong analytical, problem-solving and decision making capabilities, including ability to identify existing or potential problems and recommend solutions
Proficiency in MS Office Applications (Word, PowerPoint, Outlook, Excel)
Ability to be flexible to handle multiple priorities and to work limited overtime as necessary

HR Regulatory Performance Management & Compensation Manager Resume Examples & Samples

6-9 years of relevant HR experience: Organizational Development experience preferred; Compensation expertise a plus; Bachelor's degree (or equivalent) required
Ability to analyze and interpret data and present fact-based summaries and reports
Familiarity with HR Databases and reporting, e.g. Business Objects, PeopleSoft/GBX hierarchies

Manager, Regulatory Programs, Bmo Life Resume Examples & Samples

University Degree with 5 years + experience in compliance or compliance related function, regualtory body or equivalent business experience
In-depth knowledge of Life and Health Insurance products, services and systems
In-depth knowledge of AML regulations and regulatory expectations
In-depth knowledge of MGA Distribution channels
ACAMS Designation and LOMA Designations would be considered an asset
In-depth research and analytical skills
Must be organized, capable of handling changing and multiple priorities and work to very tight time schedules
Must be able to work independently and as a contributory member of a team
Good conflict resolution and interpersonal skills
Bilingualism – French – English, would be an asset

IT Regulatory Engagement Manager Resume Examples & Samples

Request for Information (RFI) Coordination – Coordinate the response to requests from regulators, including engaging with relevant technology groups, consistent use of existing materials and management of meetings to maintain traction on responses
Regulatory Engagement – Responsibility for interfacing with regulators where necessary, understanding the engagement model and coordinating technology regulatory visits onsite
Project Governance – Provide reporting on the progress of RFIs, track and monitor progress and maintain an issue tracker to document key issues and submissions
Interaction with Global Technology Regulatory team to ensure consistency with global regulatory process responses
Tracking of issues found by regulators to closure
Maintaining a rolling calendar of Regulatory engagements in EMEA
Providing supporting materials to the monthly Technology Regulatory Steering Group, as well as contribute to the strategy for technology regulatory management in EMEA
Maintaining the overall regulatory engagement process for EMEA, providing awareness and training on the subject to stakeholders
Prior experience of interfacing with Regulators and coordinating RFIs
A good awareness of EMEA regulators with specific interest in Technology / Security for the Financial Industry
Prior experience in one of the following control/risk related functions
Regulatory Response, IT Risk Management, Audit / Business Control, Compliance
Prior experience of coordinating and managing submissions to regulators and external audits
Strong MS Office skills (particularly, MS Excel, MS Powerpoint and SharePoint)
Strong communication skills - create effective partnerships with colleagues. Ability to work with senior managers across disciplines. Interact as the key contact for regulators
Demonstrate and foster teamwork - ability to work alone and as part of an EMEA-wide team and to make positive contributions
Client Focus - Appreciate the customer service concept. Understand and be sympathetic to needs of locations
Precision – ability to provide concise materials whilst maintaining Regulatory meaning
A technology and/or security industry certification such as
ISACA - CISA or CISM
ISC2 – CISSP
Background in Information Technology

Regulatory Paralegal / Project Manager Resume Examples & Samples

Reviewing, editing, and approving communications materials for compliance with Federal Medicare requirements
Working directly with different departments to ensure the accuracy of marketing, plan and member materials
Assisting with developing legal policies, standards, and procedures
Assisting with developing guidelines to educate various departments on Medicare requirements
Assisting with researching Medicare, Medicaid, and pharmacy legal and regulatory questions
Assisting with developing and maintaining a database of regulatory responses from outside counsel, agreements, and other legal documents
Managing Corporate projects, and support as needed
Associate’s or Bachelor’s Degree in Business, Marketing or a related field
3-4 years of paralegal or similar experience, preferably in a corporate environment
Comprehensive knowledge of Microsoft Word, Excel and PowerPoint
Demonstrated expertise in the areas of online research, proof-reading and editing
Marketing and government program (Medicare Medicaid) experience a plus

Client Regulatory Diligence Project Manager Resume Examples & Samples

Report to the regional CDA lead and act as a regional regulatory expert, for those regulations that impact the Sales department or Client Onboarding
Be a subject matter expert in existing and upcoming regulations affecting KYC/AML, including MifiD II, FinCen CDD and the 4th AML Directive
Have an understanding of Dodd Frank, EMIR and FATCA requirements
Conduct analysis of how new regulations will affect clients, including internal business processes and systems. Present these results to senior management and project working groups
Manage regulatory remediation activities, such as client outreach, document/information intake and processing. Provide full assistance to both clients and Sales as required, including providing project updates and training
Manage project teams across various departments and located across the globe
Work with Project managers to define requirements for new system functionality required, and help coordinate implementation
Track, prioritise and communicate tasks/initiatives with management and staff, and communicate any new obligations to Sales or other departments as required
Understand and communicate importance of ethics and control surrounding Credit Suisse’s regulatory compliance obligations
Maintain compliance with current firm regulatory policies and processes

Project Manager Digital Private Banking With Focus on Legal & Regulatory Matters Resume Examples & Samples

Involvement in sub-projects within the DPB program: from initial client value proposition and client experience setting to idea building, scope definition, process construction, and final implementation
Stakeholder management: engaging stakeholders/subject matter experts through formal and informal meetings, requirements gathering from all impacted departments
Identification and management of project related risks, dependencies and issues and performance of respective mitigation measures
Ensuring compliance with established guidelines for accurate and timely project delivery milestones
Assisting senior project/program managers, the project management office in overall program related tasks and duties
Identifying regulatory, legal or compliance matters and advising the Digital Private Banking teams in how to operate the digital platform and preventing issues
Driving regulatory approval or notification processes, involving relevant internal and external stakeholders
Assessment of and advisory in re-designing processes and drafting legal documents, e.g., Terms and Conditions, Privacy Policy

Manager, Regulatory Supervision Resume Examples & Samples

Responsible for the management of staff
Supervising and implementing compliance oversight procedures
Initiating inquiries on ad hoc basis into compliance matters within their scope
Oversees the compilation of required regulatory reports and filings or any other information requested by regulatory agencies
Provides compliance training to business unit personnel in formal, structured settings
Manage the supervisory principal reviews of marketing material for Prudential Retirement
Develop and maintain Subject Matter Expertise on FINRA, SEC and DOL regulations to support RS Operations and as needed for Retirement Solutions, including partnering with Retirement Legal and Compliance on Regulatory issues and new pronouncements impacting Retirement Solutions
Perform audits of work performed and materials prepared by Prudential Retirement to ensure compliance with policies, procedures and service level agreements. Address gaps as needed
Lead, train and manage the Compliance Review Team
Series 6 & 26 required (can be earned within the first 120 and 180 days in role, respectively, if not possessed at hire)
Four-year degree
5+ years work experience in financial services marketing, compliance or investments
Outstanding project management skills, the proven ability to balance team orientation with ability to work independently
Demonstrated ability to focus on and take ownership for both personal and team results (i.e.: quality, deadlines, goal-setting, and process improvement)
Possesses solid knowledge of the principles/concepts/ practices of the compliance discipline and applies them to their moderately-wide understanding of Prudential products/functions
Ability to work well under pressure and to easily adapt to changes in priorities to meet marketplace and business needs
Excellent understanding of investment concepts and/or products within the retirement market
Understanding of marketing, sales and product development culture
Superior oral and written communication skills, ability to translate complex ideas into clear and simple format
Proven leadership and management skills

Sephora Collection Regulatory & Quality Affairs Manager Resume Examples & Samples

Regulatory analysis of new color cosmetic product briefs
Pre-validation and final formula validation of raw materials and formulas based on international cosmetic's standards in force as well as LVMH's blacklist
Analysis and day-to-day management of mandatory regulatory testing required for each new product launch
Compiling necessary data to carry out the Safety assessment issued by the toxicological expert
Reviewing, advising and ensuring product primary/secondary labeling compliance
Reviewing, advising and ensuring product material/ingredient labeling compliance
Creation and updating of each new product cosmetic dossier
Overall watching and monitoring of the cosmetic regulation market to ensure we are developing toward future standards of global and US Regulatory compliance
Manage the quality and risk analysis of each new launch through specific S+/LVMH testing protocols
Ensuring all fillers and manufacturers (suppliers) apply the requested Quality tests and supplemental paperwork
Managing the non- compliances that occur during development
Work on the continuous improvement of products after launch if the need is there
Manage on site QC for first run of key launches
Familiarity with LVMH black list is a plus
Ability to speak conversational French, or fluent French, is a plus
Must have 4-5 years of relevant experience in the personal care/color cosmetics field
Must have good knowledge of EU and US cosmetic regulations
Must be proactive, precise and maintain a strong sense of analysis
Be flexible and agile with constant changes and time restraints
Microsoft Office skills including Excel and PowerPoint

Manager Regulatory Development Resume Examples & Samples

Manages a centralized regulatory monitoring and change management process to support Legal in monitoring and communicating new or amended regulatory requirements or guidance to mitigate legislative and compliance risk for HNAH
Monitors, assesses, and communicates legislative, regulatory, and case law changes for the following lines of business and central/support functions ( including but not limited to)
Private Bank (PB); and/or
Anti-Money Laundering (AML)
Minimum of three years progressive legal, audit, compliance, financial services operations, and/or regulatory experience, or equivalent
Basic (move thorough to manager) knowledge of products, services, operations, and systems and understanding of laws, regulations and regulatory agencies related to assigned areas
Proficiency with standard business IT packages (such as MS Office, Lotus Notes etc.)

Program Manager Regulatory Programs Resume Examples & Samples

Risk Appetite (Both group and legal entities)
Risk Limit
Capital Adequacy
Capital Comparison
Business performance
An Investment Bank and/or Asset Management and/or Consultancy background, with a solid understanding of structured project management within the Financial Services arena
Either
Knowledge of budgeting and resource allocation procedures

Manager Marketing Regulatory Review Resume Examples & Samples

Performing a quality check using an established process of sampling recent analyst reviews and approvals
Developing and present training based on QC results
Reporting metrics
Identifying trends and inconsistencies
Resolving inconsistencies
Series 7 and 24 registrations (required)
3+ years of recent MRR experience at LPL

Regulatory Remediation Manager Managed Services Resume Examples & Samples

Responsible for engagement planning, management, and leading teams in compliance remediation engagements and on-going compliance work
Support bids and proposals for new client opportunities and grow existing valued relationships
Work effectively as a team member sharing responsibility, providing support and updating senior members on progress
Mentor staff and conduct performance reviews and contribute to performance feedback for staff
Help upskill the wider team in areas relating to Project Management, PMO, Process Design/Mapping and / or Target Operating Model
Regulatory compliance work experience/ professional qualification expected
Technical knowledge of financial products or regulated activities (CCA, PPI)
Focus on one or more of the following areas: Wholesale Banking, Retail Banking, Wealth, Asset Management and Insurance
Leadership, project management and teamwork skills for delivery of remediation engagements and on-going compliance work
Experiences in areas relating to Project Management, PMO, Process Design/Mapping and / or Target Operating Model
Enthusiasm to be involved in marketing activity and developing the Managed Services team

Regulatory Accounting Manager Resume Examples & Samples

Work with the regulatory accountant to produce quarterly COREP returns for the UK regulated entities, ensuring disclosure is timely, accurate, current and of high quality
Work with the regulatory accountant to ensure all other reporting deadline are met
Assist in capital planning by providing regular management information and understanding the key regulatory capital drivers
Work with the regulatory business partner to understand impacts of new business initiatives and complex transactions
Assist the business partners with the ICAAP preparation
Research and analyse upcoming / changing rules and regulations
Work with the regulatory accountant to produce the semi-annual consolidated and parent financial holding company test returns and help improve these processes
Coach team members, share knowledge and help them to develop. Familiarity with all 3 Pillars
Strong understanding of financial statement concepts and principles
Skills in MS applications software (i.e. Word, Excel, PowerPoint, Outlook etc.)
Qualified accountant (ACA, ACCA or CIMA)

Regulatory Product Manager Resume Examples & Samples

Contribute to the definition of Bloomberg Regulatory business plan, elaborate requirements on development initiatives and coordinate project execution
Bachelor's degree (CPA or CFA a plus)
Big Four Experience preferred
Strong relationships with accounting firms and/or regulators
Deep understanding of capital markets and analysis
Five or more years of experience in quantitative modeling, financial reporting or capital markets project management in the regulatory space
Experience in regulatory implementation projects required
Highly detail-oriented with solid analytic skills
Superior knowledge of Microsoft Excel, statistical analysis tools and Bloomberg applications

Regulatory Monitoring Manager Resume Examples & Samples

To lead, on behalf of the Head of RMR, in monitoring qualification developments in a planned programme of activity against key criteria, ensuring that procedures and quality standards are maintained; and producing reports and other data to support monitoring, highlighting key areas for improvement
To provide a customer-focused regulatory service to the team’s internal customers, supporting them in ‘getting it right first time&#8217
To take responsibility and to be accountable for management of some team members (Regulatory advisers)
To monitor Pearson’s regulatory compliance against agreed risk criteria, and providing regulatory advice, guidance and training across the company
To manage specified services in RMR to support high quality regulatory requirements, such as framework and qualifications development and compliance, levelling, monitoring of marketing and publishing activity
To contribute to the development of a high performing team
To establish and maintain constructive working relationships within the Quality, Standards and Research Division, across the business with key stakeholders, and beyondto carry out any other appropriate activity as and when requested
To contribute to an effective team communication strategy, including with the Quality Assurance functions across the business, enabling clear messages from and to the team, encapsulated in regulatory advice and guidance issued, KPIs and other metrics the team develops
To ensure that the processes and practices for the development of all Pearson’s qualifications is effective, and produce reports to identify areas for improvement
To lead on key projects across Pearson in relation to the General Conditions of Recognition
To develop regulations and criteria as required and to provide expert advice and guidance
To establish and maintain constructive working relationships across the business
Together with the Head ofRMR, to be the central point of communication for the interpretation of regulation as it applies to qualification and associated developments
To maintain and report on a series of associated logs, to include the scrutiny of qualifications, regulatory advice, risks and issues, and associated metrics and KPIs
Provide strategic advice, expert guidance, training and support for the organisation as a whole, including executive and senior managers throughout the business, on regulatory issues within the team’s areas of expertise
Work with colleagues within the Quality, Standards and Research Division, and across the business, to encourage the development of members of the team, in accordance with good practice and Pearson’s people manager policy
To contribute to the development of an annual risk-based strategy for the team’s core functions, which ensures successful delivery of projects to the required time, cost and quality
Communicate effectively and professionally within the team and in the wider business
Represent Pearson in a variety of internal and external forums, as required
Undertake the lead or support of specific projects as directed by senior management
Experience of risk and project management
Understanding of a wide range of stakeholders involved in awarding organisations' regulation (eg publishers, sales and marketing)

Regulatory PLS Manager Resume Examples & Samples

Monitor global tracking mechanisms for GRO-managed submissions and ensure GRO delivers high quality, compliant submissions to global health authorities within required timeframes
Lead activities for non-submission regulatory reporting on behalf of GRA, ensuring GRO is managing data according to agency requirements and internal processes (e.g. Pharmacovigilance Safety Master File, XEVMPD, Drug Establishment Information)
Manage vendor interactions and internal processes for Structured Product Labelling, ensuring Shire is communicating effectively with the vendor
Maintain a fluency in use of electronic and paper publishing systems, tools and global submission formats, with hands on publishing when required
Maintain effective relationships with R&D contributing groups, ensuring timelines and requirements are mutually understood and in line with Shire and health authority standards
Participates in validation testing and requirements gathering of new and upgraded software
Delegation of tasks in a matrix environment, providing feedback to staff and their line management
Bachelor's degree is required. Scientific and/or computer science field preferred
Pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.)

Senior Manager Financial Risk Management & Regulatory Advisory Resume Examples & Samples

Lead FS Risk Management Advisory engagements with a focus on the prudential and regulatory agenda in banking
Turn business opportunities into successful projects
Act as a leader of the business and a role model for staff
Understand our full range of service offerings and actively identify and develop new opportunities to address emerging client needs
Develop your personal profile and the awareness of our offerings in the marketplace
Build strong, long-term relationships with key client sponsors
Further develop an internal and international network within FSO Advisory Services and across the other service lines, like Assurance and Legal
Be an ambassador for EY in the market and with clients

Business Project Manager Tax & Regulatory Resume Examples & Samples

Strong analytical and organizational skills. Ability to apply business and technical knowledge
Pro-active and solution oriented, enthusiastic and stress resilient
Fluent in English, German and/or French would be a considerable asset
3-5 years of working experience in a similar position before

Regulatory Finance Project Manager Resume Examples & Samples

Degree (or equivalent) in a relevant discipline
Extensive knowledge of Capital calculations methodologies and associated regulatory reporting
Working knowledge and experience of implementing Finance Change
Demonstrable ability and confidence to build relationships across Technology and Finance at all levels
Proven track record as a finance change programme manager with experience of the full analysis life cycle especially around project initiation, requirements specification through to testing planning, management and execution

Manager, Regulatory Inquiries Resume Examples & Samples

Responsible for responding to regulatory inquiries, primarily trading-related
Ensure requests are enforceable and material requested is within the boundaries and jurisdiction of the requestor
Prepare and review documentation, liaise with investigators and external counsel, draft responses and follow up with the regulators
Review may include investigating and interviewing parties involved
Analyse results of reviews to identify potential issues, escalate potential areas of risk, and make recommendations for appropriate corrective action
Act as the point of contact for regulatory inspections and examinations (including requests from regulators for data regarding client accounts, firm policies and procedures, etc.), collecting background information and briefing regulators
Responsible for interactions between the relevant firms and industry regulators, including the IIROC, provincial securities commissions, the Montreal Exchange and other regulatory bodies
Assure comprehensive tracking and reporting of all files, issues and trends arising from regulatory inquiries and inspections), report to the CCO(s) and business supervisors and prepare and deliver regular or one-time presentations to management as required
Develop relationship with peers in other firms in order to develop market awareness and build network of compliance professionals; participate in industry-sponsored committees and forums
Responsible for internal tracking systems and regulatory reporting requirements (e.g. ComSet and gatekeeper obligations under UMIR 10.16)
Monitor changes in securities regulations related to trading rules and industry technology, including monitoring and analysis of regulatory disciplinary actions
Liaise with compliance departments in the various business units on cross platform issues, including the international offices and RBC Law Group

Regulatory Accounting Manager Resume Examples & Samples

Demonstrate proven experience within the Financial Services industry.Work with the regulatory accountant to produce quarterly COREP returns for the 9 UK regulated entities, ensuring disclosure is timely, accurate, current and of high quality
Work with the regulatory accountant to ensure all other reporting deadline are met (e.g. monthly full cope entity returns, a monthly Recognised Investment Exchange submission, quarterly balance sheet and income statements)
Work with the regulatory business partner to understand impacts of new business initiatives and complex transactions (e.g. stock loans)
Work with the regulatory accountant to produce the semi-annual

Regulatory QA Manager Resume Examples & Samples

Lead the first line of defense implementation of the Regulatory Compliance Management (RCM) program for CCCMS in accordance with OSFI's E-13 guidelines
Provide leadership to determine the scope and nature of the work that allows for the most effective and efficient means to detect control issues. Ensure exceptions are appropriately reported and track to resolution by the team
Represent CCCMS to key stakeholders for the RCM programs
Proactively analyze potential risks through detailed reviews of multiple sources of information and ensure escalation of key risks to appropriate areas and senior business leaders
Create adhoc and regular executive reporting on CCCMS for issues trend, risks etc
Provide insight and guidance to business unit senior and executive management on the identification of major risk drivers and key risk indicators
Ensure day-to-day quality assurance of department and/or Employees
Manage, develop, coach and motivate Employees to achieve quality assurance goals
Monitor assigned team activities to ensure service and/or productivity standards are met
Ensure compliance to policies and procedures
Act as a backup to Senior Manager as needed

Cyber Security Regulatory Governance Manager Resume Examples & Samples

Defining and implementing repeatable processes and associated supporting tools for more effectively engaging with regulators and clients on Cyber Security topics
Working with relevant stakeholders to ensure the monthly CTM Board material (Threats/Controls/Remediation) is created and appropriate associated talking points created
Continually driving improvements to the CTM Board processes, metrics, and value the meeting is providing
Working with C& ORC to ensure a repository of Global Cyber Security regulatory requirements is created and maintained
Works with IT Risk/GISO to ensure all Cyber relevant KPC's are effectively defined and mapped to external frameworks such as NIST
Works with IT Risk/GISO to ensure missing KPC's (as defined by NIST for example) are created if applicable to firms risk appetite
Co-ordinating and completing regulatory and client questionnaires on Cyber Security topics
Works with C&ORC to maintain a pipeline of potentially new Cyber Security regulatory requirements
Initiates and manages IT business cases to develop new Cyber Security Governance capabilities
Develops strong and productive relationships with industry peers and relevant industry working groups
Provide input into the development and improvement of processes and procedures for detecting and responding to cyber threats
At least 10 years experience in Technology or technology governance roles such as Technology Risk, IT Security or IT Audit
Ability to take personal ownership for issues and drive remediation
Excellent problem analysis skills and solution synthesis
An attention to detail
Ability to understand complex issues quickly and set priorities according to technical as well as strategic considerations
Experience of working under pressure without impact on the quality of deliverables/results
Experience of influencing at senior organizational levels, up to and including MD level
Knowledge and experience of cyber security regulatory environments and industry frameworks (NIST etc.)

Ftc-regulatory Delivery Ucits V Client Transition Manager Resume Examples & Samples

Create and manage detailed project and implementation plans that define roles, responsibilities and milestones; responsible for tracking deliverables against defined milestones
Build key relationships to assist in successful delivery
Management to resolution of issues, escalation where appropriate
Maintaining a clear and accurate view of status, progress & key issues of all in-flight transitions at all times, for ad-hoc verbal queries, and presentation to management
Multi-stakeholder management – internal & external
The ability to absorb and understand new topics quickly and accurately
High energy levels combined with a flexible approach to work

Change, Process & Regulatory Business Manager Resume Examples & Samples

Actively engage as team member of CPR Management with focused, deep understanding of strategic regulatory programs (e.g. Cross-border business conduct, Tax reporting)
Ensure optimal information to relevant stakeholders and WMEI senior management
Engage as market representative for WMEI in relevant strategic programs
Facilitate the optimal involvement of PRS Functional management to enable them in facilitating front unit trainings, roll-out of process and tool changes and special case handling in the daily business
Escalate important topics to team head and WMEI management team
Strong knowledge and experience in front staff processes and tools
Experience within the Wealth Management environment, e.g. in a process, risk or business management function for at least 5 years
Strong analytical and conceptual skills and ability to understand complex front and operational procedures and processes
Proactive and self-dependent working style, self-starter with a sense of initiative who demonstrates drive and commitment and the ability to motivate others
Ability to interact with diverse stakeholders in both German and English (Italian, French or Spanish would be an additional asset)

Risk Governance & Regulatory Policy Manager Resume Examples & Samples

Collaborating in an entrepreneurial manner throughout the global firm to identify and assess strategic issues associated with regulatory policy changes
Analyzing and communicating the impact of pending reform issues across lines of business and legal entities
Effectively advising on and communicating about policy issues and implications to various constituencies, including senior management and the Board of Directors
Monitoring relevant news flow, regulatory and legal developments, market developments and reports to provide updates and insights to senior leadership team
Ability to assess impact of regulatory policy on financial products, markets and lines of business
Strong work ethic and inter-personal skills; ability to work independently
Good communication skills, both verbal and written Advanced PowerPoint skills with experience creating high level presentations

Investor Analytics Project Manager Associate to our Regulatory Solutions Group Resume Examples & Samples

Manage and maintain capital activity and performance calculations for index constituents
Liaise with other departments in the collection and approval of data
Lead monthly calls related to index production and drive overall timeline
Coordinate and verify data accuracy
Produce post-publication MIS on accuracy rates, reasons for discrepancies, etc
Respond to internal and investor related queries related to our specialized investor reporting products
Contribute to internal project initiatives regarding new product development, testing, and implementation
Bachelors degree in Accounting, Finance, or related field
3+ years experience Finance working for a Prime Broker, Administrator, Hedge Fund, Mutual Fund, Investment Advisor, Audit Firm, or Financial/Retirement Planner
Strong knowledge of the workings of the capital markets, different financial products, and fund structures
A demonstrated ability to manage complex projects and work effectively with corporate executives. Capability to implement and improve structured processes
Proven ability to work under pressure and meet deadlines
Strong knowledge of MS Excel
Access Database experience is a plus

Retail Bank Regulatory Relations Issue Management Senior Manager Resume Examples & Samples

Provide project management support for research and resolution of control-related issues that impact Retail Bank, including root cause analysis, project plan development, risk mitigation, implementation of remediation activities, and validation
Ensure accuracy and consistency of executive level scorecard metrics and interact with Internal Audit to proactively understand issues impacting these reports
Lead strategic control initiatives to facilitate improvements in Retail Bank governance environment
Assemble and lead teams of cross-functional stakeholders to confirm issue scope, identify root cause, and develop and implement remediation activities
Consult on creation and documentation of corrective action plans, driving the appropriate course of action based on knowledge of the consumer financial business and related operating risks
Manage and lead communications to a variety of stakeholders including senior leadership; these communications include standardized issue documentation, dashboards, templates, reporting, and forums to provide management and business owner issue awareness (number, severity, status) and action
Prepare and provide updates for regulators on new issues, including risk identified, progress against milestones, and any potential impacts
Monitor communications relating to issues being managed by other areas such as technology and information security to identify emerging risks. Strategic Leadership
Develop common procedures and processes for identifying, tracking, and remediating issues to ensure timely and sustainable resolution of issues within Retail Bank
Design and implement processes for rigorous management of issues identified from Regulators (MRAs), Internal Audit and Compliance Testing
Design processes to assess emerging business risks from a variety of sources including Internal Audit, Compliance, and consumers and to integrate issues identified in other lines of business to identify and prioritize potential risks
Evaluate potential issues to assess materiality (severity and scope) considering customer, reputational, regulatory, financial, and other risk factors to determine tracking, resolution, and reporting protocols
Leverage strong business process orientation and facilitation skills necessary to work with the multiple partners and lines of business
Establish strong project management disciplines and routines with clear accountability for the key stakeholders from issue identification through resolution and validation
Strong communication skills, both written and oral, with all levels of the organization, with a focus on senior audiences and regulators
Detail oriented with strong organization and project management skills. Influence/ Collaboration
Drive compliance within Retail Bank for new Issues Management procedure
Facilitate agenda for Regulatory and Audit Validation Committee and ensure complete coverage for both direct and indirect impacting issues
Engage key functional partners like Business Control, Compliance, Business Operational Risk Management, Enterprise Risk Management and Legal to ensure franchise and other key risks are evaluated and mitigated
Influence diverse stakeholders at various levels of seniority without direct reporting relationships to ensure appropriate response and sense of urgency
Create and facilitate project governance routines to remove roadblocks, facilitate decision making, and drive issue resolution across functions. Judgment/ Decision Making
Utilize strong investigative and analytical skills to ensure root cause identification, implementation of effective remediation, and design of sustainable processes
Bachelor’s degree in Business, Finance, Marketing, Technology or related work experience. MBA and/or Regulatory experience preferred
Strong technical and business writing skills
Extensive project management experience with the proven ability to develop project plans and drive a diverse group of stakeholders to achieve milestones and deadlines; Six Sigma or other relevant quality training is a plus
Familiarity with iCaps and any other existing databases used across businesses for tracking/monitoring issues
Familiarity with ORM policy and Basel requirements a plus
Detail oriented, with proven ability to question and identify opportunities within existing processes and business practices by leveraging previous experiences and knowledge of the Retail Bank business, Risk, Marketing and/or Product Support preferred
Strong relationship management skills with ability to deepen relationships and build partnerships across the NA Consumer businesses and key support areas like Audit, Compliance, Control, CAO, Independent Risk, and Legal
Working knowledge of the Retail Bank business and applicable rules, regulations, and processes

Business Support Manager Regulatory Requirements Resume Examples & Samples

Knowledge: Sound knowledge of the banking environment, its products and technologies and its regulatory framework. Holder must possess in depth understanding of end-to-end flows across multiple system applications for their assigned function as well as broad knowledge of the other functions and departments within the legal entity
Experience: 10+ years banking experience required to be able to understand impact to assigned function during strategic and/or cross-functional projects or when acting as Senior Analyst
Analytical skills: Must be able to conduct business analysis across functions and to determine business lines impacted on any given project
Risk awareness: Must have the experience and confidence to identify and raise risks and manage to resolution
Project management skills: On large projects when acting as Business SME manager or project manager will be required to ensure project resources perform key tasks allocated to them in a timely manner, which requires negotiation, issue resolution and influencing skills
Business & Technical skills: When acting as subject matter expert, the holder is required to give input to business requirements and functional specifications. During this process, the BSM will work with Technology to find solutions that lead to the Technology development. The aim is to deliver an end product that meets the regulatory requirements. When acting as project manager the jobholder will need to ensure thorough follow up on issues so that they are resolved and targets/ deliverables are met
Interpersonal skills: Where project requires analysis to determine feasibility, the jobholder will draw on their business knowledge and expertise to propose a solution. For their assigned project, the jobholder is responsible for ensuring the end deliverables meets the requirements i.e. fit for purpose. To achieve this, the jobholder will be required to draw on their knowledge and understand where it is necessary to call in others to participate in the compilation of business requirements and the development of the functional specification. The jobholder will interact with other groups during projects/assignment lifecycle and when dealing with issues raised by those groups e.g. Business Program Services, Change Management, Technology Services and Risk Management
Management skills: He/she will have strong management qualities in order to manage project resources as required and lead on projects. Requires the ability to persuade, influence others and communicate effectively with all levels in the organization, including Senior and Executive Management and occasionally, external industry parties
Education: Bachelor degree or equivalent. Master degree level preferred. Professional project management qualification
Languages: English fluency

Regulatory Developments Manager Resume Examples & Samples

5-7 years of regulatory/legislative/financial services experience
Strong critical thinking and problem-solving skills
Strong interpersonal skills with the ability to establish credibility and foster excellent working relationships with internal and external stakeholders
Sound project management capabilities

AVP State Regulatory Administration Manager Resume Examples & Samples

Supports regulatory compliance adherence responsibility driven by the line of business supported. This position supports the following lines of business, including but not limited to: Consumer and Mortgage Lending and RBWM
Has knowledge of state licensing and regulatory reporting laws, rules, and regulations
Has knowledge of municipal licensing procedures
Has functional knowledge of the Nationwide Mortgage Licensing System
Has knowledge of examination support and management
Minimum of six years proven and progressive regulatory compliance and/or legal management experience or equivalent
Proven experience managing regulatory relationships and examination management experience
Minimum of a Bachelor’s degree in business, related field or equivalent experience
Strong communications, interpersonal, analytical, organizational, project management, document production and planning skills
Strong knowledge of assigned businesses, products, operations, systems and organization and full understanding of all significant regulatory compliance requirements applicable to the business

Project Manager Regulatory Projects Resume Examples & Samples

Develop and track project plans including managing deliverables and dependencies across projects
Manage project prioritization and resource allocation across programs
Report on the multiple programs simultaneously
Budgeting and cost management of actual vs. plan
Management of Managed Expenditure Requests (MER) for consultant on-boarding including invoice tracking for actuals vs. budget
Facilitate testing management of the automation deliverables
Facilitate decisions as they relate to risks, boundary issues, timelines, scope and resources
Ensure communication and information transparency to key stakeholders and senior management
Work closely with central Finance Change the Bank and Financial Holding Company teams to ensure their risk management and reporting deliverables are met
10+ years of project management experience in the Technology or Finance department of an investment bank / financial services company
Developing and tracking project plans, as well as forecasting and tracking budget
Testing management
Strong organization skills and ability to manage multiple projects simultaneously
Program reporting to senior management and central teams
Advanced Microsoft Office skills (PowerPoint, Excel, Access and Project)
Experience with external regulatory filings (preferred)

Senior Program Manager Regulatory Resume Examples & Samples

Delivers programme benefits defined by the business stakeholders on time within budget whilst adhering to organisational quality standards
Develops and maintains an integrated portfolio plan (consolidation of project plans and schedules) for the various Tax programmes
Successfully manages scope through effective change control, and project management principles
Effectively manages dependencies and constraints across the projects, departments, regions and countries in the Tax programmes
Establishes the programme governance structure to best deliver the strategic aims and solve the challenges of the Tax and Regulatory domains
Manage Project Working Group committees, and leads the Steering Committee meetings on behalf of IT PBWM APAC
Champions standards and takes corrective action when they are being breached
Reviews team project documentation related to Project Management for quality and accuracy aspects
Ensures stakeholder satisfaction through effective communication and delivery of scope
Seeks to understand, prioritise and unite multiple stakeholder agendas with different and potentially conflicting objectives
Consultative – i.e. the candidate must be approachable and sought out for consultation by the business regarding their IT issues and challenges
Anticipates possible conflicts and difficult interpersonal situations and takes steps to avoid them manifesting
Innovative - Drives the adoption of new processes or techniques to manage project implementations
Efficient and Effective

Regulatory CMC Associate Manager Resume Examples & Samples

2+ years of experience in a Regulatory field
Bachelor's Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Solid research and analytical skills
Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
Experience with Regulatory CMC

Regulatory Control Change Project Manager Resume Examples & Samples

Take responsibility for the delivery of specific projects within the Reporting stream of the Operations Regulatory Control Change Management roadmap
Drive the implementation of regulatory initiatives with members from Operations, Technology, Compliance, Legal and the Business
Ensure completion of all appropriate project documentation throughout all stages of the project lifecycle from initiation to project close out
Identify key change initiatives that will centralise the firms reporting, minimise cost and risk and maximise benefit
Good project management skills and experience of managing medium to large projects
Broad experience in matrix managing multiple teams of different work streams
PMP/PRINCE2 or equivalent qualified advantageous
Resilient and tenacious

Global Regulatory Product Manager Resume Examples & Samples

Self-directed, highly driven, seasoned leader with extensive experience in operational aspects of the business. � Possess an understanding of services as well as product strategy, operational functions, regulatory requirements and industry best practices. �
Demonstrated ability to work with cross-functional lines of business and prioritize accordingly. �
Knowledge of risk management techniques and proven ability to assess business processes for efficiency & control design. �
Experienced manager who is able to work with virtual teams
Strong communication, negotiation and analytical skills are necessary to provide consultation at the highest technical level with partners throughout the organization as well as regulators and auditors
Effective project management skills are essential to help drive various initiatives. �
Strength of character, accompanied by excellent interpersonal skills, to enable the optimum balance between exercising firm command of a situation while maintaining the support and buy-in of senior management. � Demonstrated ability to work with senior level partners across an organization. ��
A level of salesmanship is necessary to sell the value added benefit of the control discipline and drive improvements

Manager, Risk & Regulatory Programs Resume Examples & Samples

5+ years of financial or securities industry experience
3+ years experience in an AML/Regulatory Compliance and/or Risk and Control role
Professional Accounting Designation or MBA degree
Knowledge of WM businesses
Analytical skills and good judgement are extremely important
Must possess excellent negotiation and listening skills
Must be organized and be able to work to very tight time schedules
Must be independent and confident enough to defend their views in an open forum
Communication skills, both oral and written, must be exceptional
Good conflict resolution and interpersonal skills. Tone of communication must be professional. The compliance officer must also be able to provide a thorough explanation of the sequence of events surrounding the issue(s) in question
Able to recognize and handle sensitive and confidential information
Change management expertise
Project Management knowledge
Resource planning (working)

Regulatory Reward Manager Resume Examples & Samples

Act as an internal subject matter expert on EU remuneration regulations, and be prepared to provide regulatory updates to various stakeholders within the firm
Work with a cross-functional team (HR, Compliance, Legal, Risk & Finance) to evaluate and recommend solutions for Invesco’s remuneration policies and practices within a continuously evolving regulatory landscape in EMEA
Draft regulatory disclosures, policy statements and required remuneration reports
Create, maintain and execute against a schedule of on-going remuneration compliance activities such as multi-tier review and approval of identified staff lists, remuneration policy statements, disclosures for covered entities and funds, etc
Conduct compensation analysis for both remuneration regulation matters as well as broad-based and incentive compensation plans as needed
Conduct modelling of compensation plans (for EMEA or other business areas) to determine financial impact to the business
Create presentations of compensation policies and analysis for use with colleagues and senior management
Take on other duties and responsibilities as needed
Bachelor’s degree and/or equivalent work experience
Previous experience with at least one of the EU financial services remuneration regulations required ( AIFMD, UCITS, MiFID)
Previous analytical role in compensation or related field (finance, compliance, legal, etc.) required
Previous experience in asset management, banking or consulting required
Previous experience drafting policies, disclosures and reports, preferred
Excellent communication/presentation skills (written and verbal)
Ability to work in a global team environment with your manager, colleagues and stakeholders in different time zones across world

Regulatory Engagement Manager Resume Examples & Samples

Assists the business process outsourcing development teams in gathering and summarizing data to assist in client evaluation. Accompanies the sales team, as needed, to client sites
Provides analysis and documentation of client requirements to provide appropriate data to outsourcing project development and implementation teams for client(s)
Prepares work plans, documents project scope and reviews with client to ensure accuracy. Monitors project schedules to ensure timelines and deliverables are met
Demonstrates system setup to clients before system is finalized. Tests and analyzes system configuration against requirement documents during implementation and administration
Monitors processes and resolves participant issues; escalates as appropriate
Bachelor's degree or equivalent combination of education and experience
Bachelor's degree in business administration, information technology, computer science or related field preferred
Two or more years of business process outsourcing, consulting or systems implementation experience
Experience working with business processes
Experience working with information technology applications and infrastructure
Communication, presentation and facilitation skills
Ability to conceptualize, develop and apply business and management consulting applications and services
Ability to assess clients' business and identify improvement opportunities

Ofsaa Manager Regulatory Capital Resume Examples & Samples

4+ years of relevant experience in OFSAA implementation/functional advisory with total experience between 4 to 8 years
Should be well conversant with OFSAA Regulatory Capital (Basel III, Credit Risk Management, Market Risk) products/technologies, frameworks, business metadata management and relevant architectural components
Strong in functional knowledge of Basel III Regulatory compliance guidelines for Market and Credit Risk
Strong in functional design and configuration of LRM and ALM applications
Strong Understanding of OFSAA data model
Should be well versed with the Standardized and IRB – Foundation & advance approaches suggested by Basel committee for credit risk
Should have knowledge of VaR and VaR calculation methods for market risk
Command over all types of instruments and products involved in the system
Strong command over OFSAAI staging and reporting data model
Should be versed with SQL-PL/SQL and ability to design transformations
Deliver large/medium OFSAA Risk programmes, demonstrate expert core consulting skills and advanced level of OFSAA knowledge and industry expertise to support delivery to clients
Be accountable for the performance and results of each assigned requirement development. for example, presales, internal engagement and / or knowledge management
Demonstrate man management and an ability to conduct and lead consultancy assignments
Strong understanding of data lineage. Proficient in building and extending load utility tools such as OFSAA Excel File Upload, File to Table (F2T) and Table to Table (T2T), Unified Metadata Manager, SCD, AMHM, etc
Maintaining end-to-end accountability and expectations for customer satisfaction and overall delivery excellence
Prioritize deliveries in conjunction with implementation team
Adopt a proactive, logical and organized approach to problem resolution

Manager, Regulatory Communications Resume Examples & Samples

Manage and coordinate the development, production and distribution of all regulatory communications, for the investment solutions offered by RBC Global Asset Management. This includes making proactive recommendations with regards to design, content, clarity, production and distribution of these documents
Ensure consistency of commercial and legal version of regulatory communications. This includes working closely with the agency to coordinate all changes to commercial drafts of communications based on changes to the legal documents
As regulations change and new instruments come into effect, work closely with the legal and product team to implement these changes, keeping RBC Global Asset Management as an industry leader in mutual fund governance
Manage the budget allocated for development and execution of regulatory reports
Constantly benchmark competitors’ regulatory documents and make recommendations as to how we can improve our communications
Develop and execute internal and external communication strategies in support of regulatory communications including web properties
Manage production related to monthly/quarterly fund including relationship with the vendor and review/editing and production of quarterly commentaries
Assist in ad-hoc marketing communications
University undergraduate degree or equivalent
Proficiency in Word, Excel, PowerPoint and Adobe PDF

Manager Regulatory Change Resume Examples & Samples

Reviewing of the existing global operating model with the Regulatory Reporting BAU team
Working with the Technology team on the development of a new user interface for the internal reporting platform
Analysis of MiFID 2/MiFIR Regulatory Technical Standards
Working with project leads from across the programme to identify impacts to MOD (Market Operations Department)
Working with existing projects to ensure any requirements are delivered within the required timeframes, and creating new project to deliver business requirements
Draft business requirements for sign off by key stakeholders
Work with the wider MOD team to support other change initiatives
Support the development of a revised operating model for the Regulatory Reporting BAU function

Regulatory Consulting Manager Resume Examples & Samples

Engaging with current and potential clients and building relationships with them
Preparing and supporting senior management with the submission of regulatory proposals
Supporting the wider financial services team
Engaging with other parts of the firm (Ireland and internationally) and network to promote the Regulatory Consulting services
Member of the financial services management team
Delivering high quality client projects
Complying with the firms quality and risk standards
Drafting practical thought leadership articles and publications on topical areas of regulation
Supporting business development initiatives
Carrying out other ad hoc support and projects
5+ years in consulting with proven expertise/knowledge in one of the following areas: AML, MIFD, AIFMD, Solvency II
In depth knowledge of the regulatory environment within the financial services sector (banking, insurance or funds)
A recognised University degree or equivalent (minimum grade 2.1)
LCOI or equivalent qualification confers advantage
Previous project management and business development experience is distinct advantage
Skills required: Strong inter-personal skills
Strong analytical and report-writing skills
An ability to lead multi-disciplinary teams
Strong communication skills, specifically an ability to express ideas clearly and concisely verbally and in writing
The ability to interact with various levels of clients and firm management

Regulatory Records Manager Resume Examples & Samples

Develop and maintain efficient tracking mechanisms for all global regulatory information related to registration data, agency correspondence and submissions to Health Authorities, including the archiving and storage of both electronic and hard copy records
Receive and process documentation of Shire’s product information and internal/external correspondence with global Health Authorities, ensuring the information is stored, maintained and tracked according to Shire standards and processes
Manage hard copy records storage by collaborating with facilities and offsite vendors for the storage, tracking and retrieval of Shire records
Create and maintain effective relationships across GRA, R&D contributing groups and IT, ensuring information management needs are met and requests for information are handled in a timely fashion
Manage Regulatory’s contribution to overall Shire Records Information Management team by ensuring GRA policies are communicated and adhered to for records management
Serve as the Regulatory point of contact for R&D Records and Information Management activities and strategies (i.e. RIM Steward)
Remain current with new electronic submission and regulatory documentation practices issued from global health authorities
Provide Subject Matter Expertise for technical registration tracking and document management tools and provide efficiency/enhancement proposals for these platforms
25 %
Support Shire portfolio expansion by assessing how best to incorporate new products into Shire Regulatory Information Management systems and processes
Contribute to new and updated process and standards
Work within a matrix environment to support Global Regulatory Operations and Global Regulatory Affairs initiatives
Participate in validation testing and requirements gathering of new and upgraded software
Collaborate with GRA employees/consultants within a matrix environment
Participating in interviewing, hiring and training employees/consultants for special projects, e.g. integration activities
Planning, assigning and directing work in a matrix environment
8 - 10 years of pharmaceutical experience in an R&D environment
3-5 years of experience in electronic document management technology
Knowledge of the requirements for electronic submissions to regulatory authorities. Experience in the preparation and submission of documents using regulatory/document management systems (e.g. Documentum®, FirstDocs®,eCTDXpress, Validation tools) is highly preferred
5 years of technical support and Information Management experiences from User support and strategic level, preferably within a corporate environment supporting multi-user systems

Manager Regulatory Projects Resume Examples & Samples

The incumbent acts as the Sites’ primary contact for regulatory support. This support consists of: working with the sites and other stakeholders to see that cost-effective, automated and timely solutions are developed for regulatory changes
Managing the implementation of the Basel III Operational Risk Capital standard, including developing sceanario analysis and stress testing
With the assistance of resources throughout the International Division, the incumbent will be responsible to create and/or modify processes to improve and simplify Regulatory Reporting
As part of the above accountability, the incumbent will ensure that all International Branches and Units’ Regulatory requirements are captured and maintained on a matrix/data base
The incumbent will work with management throughout the Division to develop a monitoring program to ensure the reliability of reporting; and providing advice and counsel where required
The incumbent is to aquire and maintain an awareness of global regulatory changes and work with the necessary parties to determine the required actions to be taken to accommodate the changes within the Bank’s operations and/or systems
Familiarity with local cultures, market practices, working environments and regulatory requirements in the countries in which Scotiabank operates

Business Project Manager Regulatory Projects Resume Examples & Samples

Managing the implementation of regulations (i.e.: Mifid II, EMIR, FATCA, AEI, …)
Leading project management activities (project and resource planning ; tasks completion monitoring; conducting and facilitating meetings)
Driving change management in collaboration with Business Owners
An interesting, challenging position in a striving, highly motivated, multicultural team, acting in a dynamic and international environment

Senior Business Project Manager Tax & Regulatory Projects Resume Examples & Samples

Managing the implementation of regulations (i.e.: Mifid II, EMIR, FATCA, AEI, …)
Managing end-to-end business implementation including formulation of business requirements for IT systems changes and the set-up of services with third-party providers
Acting as the key point of contact for Business Owners, IT and third-party providers
Leading project management activities (project and resource planning ; tasks completion monitoring; conducting and facilitating meetings)
Ensuring collaboration across teams locally and internationally
Driving change management in collaboration with Business Owners
An interesting, challenging position in a striving, highly motivated, multicultural team, acting in a dynamic and international environment
A broad variety of career opportunities
An attractive compensation package, including social benefits

Project Manager, Regulatory & Control Resume Examples & Samples

Coordinate teams on regulatory exams and audits to support internal and external deliverables
Manage Project Plan for alignment with business goals and resourcing as well as to ensure completeness, identification of dependencies, risk and slippage
Assist in submitting technology requests, writing technology requirements and test plan scripts for seamless delivery of regulatory projects. Support post production project testing
Support Management Control Assessment for the Banking Products team, including oversight and adherence to established product policies and quarterly management reporting
8 to 10 years experience, financial services preferred
Demonstrated project management skills and ability to drive large scale projects

Risk Regulatory Engagement & Adherence Manager Resume Examples & Samples

Organize and participate in regular and ad hoc meetings with regulators and auditors with an emphasis on Credit Risk related matters
Overseeing the effective management of findings including collating and reviewing closure requests for review by governance forums
Proactive management of open findings across all Risk functions with an emphasis on Credit Risk related matters
Review thematic and root cause analysis on findings
Actively seek to raise awareness of industry trends and opportunities and apply industry best practices on Credit Risk and other Risk matters
Coordinate and provide consolidated responses for new proposed rules / consultation papers / surveys impacting Risk Division with an emphasis on Credit Risk related matters
Attend working groups to discuss and review new and changes to existing rules and regulations on Credit Risk and other Risk matters
Liaise with other Risk functions to ensure that self assessments are completed for rules and regulations
Present thematic analysis on emerging regulatory trends to senior management and governance forums

Manager, Regulatory Policy Resume Examples & Samples

Provides vehicle development and design direction through interpretation of federal and state regulations, and develops comments on proposed rules, notices, and requests for comment
Drafts petitions for reconsideration and rule-making and requests for interpretation for submission to government agencies
Serves as VWGoA representative to industry committees, governmental agencies, VW and Audi AG, and other internal and external entities for active safety and advanced technology matters; represents VW Group persuasively in external meetings and forums such as: NHTSA; FHWA; RITA; Transport Canada; State regulatory authorities; trade associations; SAE/ISO; etc.)
Authors and publishes white papers for industry and governmental use
Provides technical policy development expertise on active safety and advanced technology topics (e.g., driver distraction, connected and automated vehicles, functional safety, etc.), including on pending federal and state legislation
Responds to government inquiries and requests related to active safety and advanced technology
10+ years of government and regulatory affairs experience
10+ years of committee membership (Alliance, SAE, ISO…)
Bachelor’s Degree in Engineering, Science or equivalent
Law Degree (Juris Doctor or LLB)
Technical expertise in active and passive automotive safety technology
Expert knowledge of active safety systems and applicable regulations
Expert knowledge of North America legal and governance systems, including detailed knowledge of regulatory authorities with jurisdiction over the automobile industry
Previous committee member experience, including in leadership positions
10+ years of experience working with trade associations and government agencies

Equities Regulatory Programme Manager Resume Examples & Samples

Running all aspects large regulatory programmes (specifically TESS) for Prime Business impacted by regulatory change
Completing delivery of the programmes end to end
Managing programme stakeholders at all levels
Managing commercials, contracts and billing with external suppliers, for example, Accenture, Galatea
Identifying architectural and process improvements that can be implemented alongside regulatory change

Regulatory Consulting Manager Resume Examples & Samples

Bachelor's degree required, emphasis in accounting, economics or finance preferred, strong accounting skills required
3-5 years of experience in telecommunications regulatory reporting and/or accounting
Knowledge and understanding of telecom accounting, separations and cost studies, and regulatory issues affecting telecom industry
Client service oriented (internal and external)
Demonstrated ability to build strong relationships with clients and industry leaders
Problem solver with good judgment and ability to think strategically
Proficient in excel with experience in financial modeling preferred

Regulatory Project / Programme Manager Resume Examples & Samples

Experience of Project or Programme Management of Regulatory Change initiatives
Experience in delivering FATCA, Financial Crime, Conduct Risk or Customer Protection initiatives
Strong senior stakeholder management experience, and a track record of delivering change

Consumer Regulatory Report Senior Manager Resume Examples & Samples

BS degree in Econometrics / Finance
Conversant with PC skills, in particular, Excel, PowerPoint and Words
High responsibility, interpersonal and problem-solving skills
Willing to work under pressure
Good communication skills both in English and Chinese
Good at time management

Manager, Regulatory Risk & Compliance, Advice Resume Examples & Samples

Excellent understanding of the Australian Financial Planning industry, and the end-to-end operation and management of the AMP Advice businesses
Ability to constructively challenge, consult and advise, whilst maintaining excellent relationships
Ability to effectively negotiate, influence and engage a broad range of internal and external stakeholders
Strong communication skills, both written and verbal, to inform or influence specific audiences
Sound organisational planning and implementation skills, and demonstrated ability to apply them in rapidly changing business environments
Ability to implement, monitor and report on risk management and compliance frameworks, risks and incidents across multiple businesses
You will have strong analytical skills and the ability to think laterally and strategically
Relevant experience and a proven track record in a risk management, compliance, internal / external audit or assurance role, with experience in financial services an advantage
Demonstrated experience in establishing and maintaining effective stakeholder relationships at a range of levels
Proven ability to manage change effectively

Manager Regulatory Policy Resume Examples & Samples

Thorough understanding of the law and the process for development, interpretation and implementation of regulatory obligations
Analytical skills with proven problem solving, interpretation and attention to detail capabilities
Strong written and verbal communication skills
Able to build strong, open and collaborative working relationships
Able to manage priorities and conflicting issues in a professional manner
Strong knowledge of banking instruments, products and processes

AIS Team Manager Regulatory Control Resume Examples & Samples

Managing staff, providing direction and technical expertise, resolving problems ensuring timeliness of work. Ensures performance management, training and development, coaching, and engagement of staff
Secondary review and approval of investor subscription documents or secondary review and/or preparation of regulatory reporting
Reviewing subscription documents for clients subscribing to AIS’s fund of funds’ custody services and/or review of regulatory reporting
Review wire packets for third party transactions; log third party transactions and report same to compliance and/or evaluation and enhancement of regulatory reporting processes
Other AML/Compliance ad hoc projects (requests from Global and/or AML Compliance, assist managers with audits/Compliance monitorings, etc.)
The AIS Regulatory Control Group works integrally with the various departments within AIS including, but not limited to Investor Services, Fund of Funds Custody, Client Service, Accounting, Tax and Relationship Management/Sales. The Incumbent would manage a group of Regulatory Control Specialists, including assigning and reviewing work and preparing employee evaluations
Additionally, the Incumbent would liase with other departments within both AIS and BNY Mellon regarding audits, review of initial client offering memoranda and subscription documents and provide periodic reports to the Global Compliance divisions
The Incumbent must have deep technical knowledge of alternative investment servicing and related regulatory requirements across multiple jurisdictions
The AIS Regulatory Control group works in an environment that doesn't always have a clear answer. The Incumbent will have to often think outside the box and work both with the AIS client, the client's investor(s) and BNY Mellon's compliance/legal/risk divisions to ensure that any decision reached regarding an AML/Control issue is resolved satisfactorily and does not in any way put BNY Mellon at any regulatory or reputational risk
Must have excellent informed judgement
The AIS Regulatory Control Group assists the various departments within AIS abide with the regional regulatory and legal obligations in connection with AIS's role as a hedge fund administrator and service provider
The incumbent would manage a team of Regulatory Control Specialists in order to implement policies and procedures to affect the above goal. In connection with same, the Incumbent may be the primary escalation point for all AML, tax and other regulatory queries raised by the Regulatory Control staff and/or the other AIS departments the Regulatory Control supports (i.e., Investor Services, Fund of Funds Custody, Client Service, Relationship Management/Sales, etc.) and any regulatory reporting process the Incumbent manages for the assigned products and assigned region
Failure to perform the function well could lead to significant legal, financial and reputational risk for the Company

Senior Program Manager Regulatory Reform Resume Examples & Samples

Accountable for the successful delivery of work stream deliverables in line with overall project objectives and timescales
Understanding of Front Office trading processes across the full trade lifecycle within a large bank/dealer covering multiple asset classes. Experience of trading desk market risk management processes desirable
Exposure to global markets
Excellent verbal and written communication skills, to effectively produce procedural documentation and communicate with senior management. Ability to seamlessly communicate complex technical issues to non-technical colleagues

Project Manager Regulatory Change Resume Examples & Samples

Oversees the Regulatory Reporting systems application support activities including management of risks, issues and release management
Controls the UAT validation & production deployment of completed projects
Validate functional specifications, and perform business solution design in conjunction with Regulatory Reporting Change Team, Finance Systems, Finance IT, and Risk
Leads and provides direction and guidance for a wide array of activities associated with project planning and management to ensure that projects are completed on time, within budget and to client specifications
Manages and oversees the end to end project management activities such as project reporting, project planning, issue / risk identification and tracking, scope management, estimation, client management, relationship management and other project documentation preparation for projects of high complexity
Develops detailed project plans and schedules projects, including goals, risks and resource allocation. Monitors project results for significant deviations acting as day to day project lead for the purpose of planning work and identifying critical tasks
Elicit business requirements from business users and subject matter experts
Analyse and interpret data sources for identified reports in order detailed business and process requirements
Identify data and business process “shortfalls” for the purpose of identifying gaps in current and/or proposed workflows
Determine current reporting recipients, benefits, and criticality as part of opportunity assessments
Manages vendor and client relations to ensure that service expectations are developed and met. Maintains regular contact with clients and coordinates and reports on project progress and accomplishments
Serves as a liaison between clients and internal groups to ensure delivery of projects on time, within budget, and to specification. Manages communication with the business at a detailed functional level and discusses/resolves issues. Manages client expectations and ensures project delivery
May coordinate resources across organizational boundaries

Regulatory Developments Manager Resume Examples & Samples

Heavy emphasis on MiFID II Regulation such as interpreting regulations and drafting policy
Advising stakeholders on regulatory impact and develop training when required
Liaising with local teams in global jurisdictions with regards to regulatory change
This is a core regulatory developments role and as such in depth experience within this area is essential
Prior MiFID II experience highly advantageous
Other reg knowledge can include - EMIR, AiFMD or SMR
Experience dealing with forums/trade associations - BBA etc

Manager, Regulatory Medical Device Resume Examples & Samples

Provide subject matter advisor support to clients related to the Medical Device Directive (MDD) - Directive 93/42/EEC and the draft EU MDR Law (European Medical Device Regulation)
Lead client workshops to determine future state processes needed to accompany medical device regulations
Educate clients in regards to the process and data requirements needed to successfully arrange government regulatory reporting capabilities for EU and U.S. medical device regulations
Articulate the detailed steps involved in performing a technology enabled regulatory transformation as it relates to regulatory submissions and health authority commitments
Identify the master data elements, supporting processes, and overarching governance principles required to maintain high regulatory data quality
Lead strategy and road mapping discussions related to achieving regulatory compliance across master data, labeling, QA, IT, and regulatory departments within a medical device company
Minimum five years of project management experience within a regulatory medical device environment including but not limited to European medical devices; minimum three years working in regulatory or QA of medical devices
Bachelor’s degree in Business, Computer Information Systems or a related field from an accredited college/ university; certifications with relevant associated years of experience applying PMP, ITIL, TOGAF, and GxP is a strong plus
Exposure to Medical Device Directive (MDD) - Directive 93/42/EEC and experience with the European Parliament, European Council, or European Commission regarding medical devices (e.g. involvement in a working group)
Past involvement or time spent analyzing the new draft EU MDR Law (European Medical Device Regulation)
Experience with notified bodies, registrations to heath authorities, tracking ministry of health correspondence, and commitments

Manager, Regulatory Risk Resume Examples & Samples

Take a lead role in the development and implementation of new compliance methodologies and protocols as laws change and new regulations emerge and assess Regulation SCI
Participate in business development and relationship management efforts; write and present clear and concise reports and presentations containing meaningful recommendations
Contribute professional articles to industry and regulatory publications; write white papers on regulatory issues and developments; prepare regulatory practice letters addressing current developments
Bachelor's degree from an accredited college/university
Experience with OATS, Electronic bluesheets, and/or LOPR preferred
Strong technical knowledge of regulatory requirements and understanding of trading rules such as Reg SCI, Reg M, Trade Reporting, Reg SHO, and other trading related regulations
Excellent interpersonal skills with a demonstrated ability to gain the confidence and respect of various levels

Associate Manager, Regulatory Supervision Resume Examples & Samples

Review, and analyze TIC data submitted by multiple data providers to ensure it meets expectations and requirements. Aggregate data from all sources; prepare summary results deck, present results to management and file reports on time and accurately to the Fed
Ensure TIC policies and procedures are maintained and followed by all parties involved in the data gathering process
Help create and implement a data collection solution for the upcoming FR 2085
Prepare, review, and analyze portions of the FR2085 once it is submitted
Assist the Fed Reporting group in coordinating and completing recurring requests from regulators, such as the annual International Association of Insurance Supervisors (IAIS) data collection exercise and Field Test
Help answer ad hoc queries from group regulators, The Regulatory Coordination Office (RCO) or management
Assist others within the Fed reporting group on ad hoc projects and requests
Help monitor and communicate changes to regulatory reporting requirements

Manager Regulatory CMC Resume Examples & Samples

25% Develop global CMC regulatory strategy for one or more investigational and marketed products
20% Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
15% Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies
10% Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines

Manager, Regulatory Relations Resume Examples & Samples

Position may require travel to various DFS locations to support regulatory activities
Provide input for Regulatory Coordination & Bi-Weekly Exam Management meetings
Keep current with emerging regulatory topics and best practices
Assist in non-examination related regulatory activities and other similar regulatory requests

Manager Regulatory Initiatives Resume Examples & Samples

Please note that this is a 1 year contract role
The team will be evaluating the in force block of historical mutual fund trades and performing supervision assessment of the block against recently implemented Dealer Policies
Must understand the Dealer Policies and Dealer business
Uses effective issue and risk management escalation governance
Putting daily and weekly plans in place and seeing through execution of any corrective action recommendations and decisions on a schedule to meet project and operations timelines
The Supervisory Managers will be accountable to perform data analysis, identify issues, construct recommendations, and follow through on execution of approved management action plans
Assesses risks and make recommendations to process change where gaps exist
Data mine information related to Dealer in force business for assessment
Tracks outcomes and reports on success criteria
Liaise between Sun Life’s Compliance Dept. and the Dealer
Compliance training and consulting for advisors, FC management, FC staff and staff of advisors
Build and maintain relationships with FC Management, staff and advisors
Able to critically judge cases and not afraid to make recommendations that may result in account rebalancing
Monitor advisors to ensure compliance with regulatory requirements and duties and following company policies and practices including the code of business practice
The Supervisory Manager will partner in the design and on-going development of first line trade supervision programs and; influence development of best practices for Tier I Associate Supervisory Managers
Communicate changes to the Dealer Operations staff, sales force and internal partners
Execution of the end-to-end processing to support certain Dealer’s regulatory initiatives for the in force block business
Conduct Client file reviews for mutual funds by phone with end-clients of in force business, including completion of a client Investment Risk Questionnaires that supports trade supervision
Delivering daily quality client service to support the CSF
Work will include Supervision on transactions related to the existing business
Reviews will be done by phone in Waterloo with clients and advisors across Canada
Working off hours or in the evenings will be required to address regional time differences
Proven customer service skills and in depth knowledge of the customer service systems, technologies and procedures within the organization
Completion of weekly Senior Management reports are required to track results
Excellent oral and written communication, facilitation and presentation skills
Responding to client complaints and concerns at the financial centre level
Trigger METS reporting and trigger Client Relations investigation
Initiate client acknowledgement process
Engagement with Compliance on Market Conduct matters
Any other related front line compliance tasks that may arise

Manager, Regulatory Records Resume Examples & Samples

Manages the daily work flow for the Regulatory Records team. Monitors productivity and quality of department outputs functions. Assigns resources to accommodate ongoing workflow
Works closely with functional team management to ensure deliverables in accordance with relevant Standard Operating Procedures (SOPs)/Work Instructions (WIs). Trains staff on proper procedures and processes
Prioritizes work for the Regulatory Records team. Assists in resourcing to accommodate on-going workflow
Creates and maintains the document repository, scanning, and indexing for all study-related documents. Receives, inventories, routes and maintains applicable project documents (e.g. clinical documents and clinical files as well as project specific regulatory documents, etc.)
Responds promptly to each request received for a project document or project file, and insures timely and appropriate delivery, as well as timely and accurate re-filing all project documents and project files. Insures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room
Ensures the security and compliance of all documents related to active and archived projects. Ensures that all project documents are maintained in accordance with relevant SOPs/WIs
Ensures prompt responses to each request received for a project document or project file; ensures timely and appropriate delivery, and timely and accurate re-files all project documents and project files. Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room
Upon study closure, prepares subject files, prepares inventories, and assists in reconciling files; ships files to client and or off-site storage

Manager Regulatory Economics Resume Examples & Samples

Degree in Business, Economics or Engineering with minimum 3 years of relevant work experience
Experience with telecom industry or other regulated capital intensive industry; working understanding of technologies used in Wireline and Wireless networks
Experience with financial modelling
Experience with regulatory costing methodologies and/or activity based cost accounting a plus
Ability to work independently and within a team environment and manage projects and timelines
High degree of proficiency with technology (Excel is mandatory, Microsoft Office, SharePoint)
Attention to detail, ability to manage large volumes of data

Manager, Regulatory Strategic Planning Resume Examples & Samples

An integral member of the Regulatory Affairs, Global Product Strategy department, the role has operational accountability over activities touching all Regulatory Personnel around the globe
This role will create and direct strategies and operations for global matrix teams and interact heavily with other Regulatory functions
Manage multiple projects simultaneously working directly and in collaboration with other key functions
Direct, develop and manage the Regulatory Excellence model which includes monitoring and assessment of success in meeting set criteria around several key modules
Develop and direct key initiatives in collaboration with the Therapeutic Area Heads
Manage budget preparation, monitoring and communications
Manage metric collection, monthly reporting processes, and system collection
Build and adapt structures, systems and resources in support of ongoing activities
Demonstrate innovation in the project management and creation of operational deliverables
Enlists and actively involves a variety of internal and external contacts to shape business decisions
Apply broad based business experience and education to develop strategies, processes and systems in support of changing internal and external business environment
Takes action to incorporate diverse, cross-boundary perspectives into strategies & tactics that consistently enhance Regulatory’s ability to deliver

Manager, Regulatory Strategy Resume Examples & Samples

Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
Represent Regulatory as a team member, covering CMC, clinical, labeling, and post-approval change activities
Provide in-depth reviews of protocols, reports, presentations, press releases, and documents
Serve as a primary contact with the FDA; document regulatory contacts with health authorities
Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items
Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
Provide risk assessments and recommendations for various regulatory scenarios

Manager, Regulatory Labeling Resume Examples & Samples

Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. (80%)
Participates in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical trials. (5%)
Mentors the junior staff members in labeling project and process management to build labeling expertise. (5%)
Prepares the submission ready labeling documents including the SPL and packaging artworks. Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate. (5%)
Monitor the worldwide regulation changes pertaining to Labeling regulations and maintain the labeling SOP and work instructions. (5%)

Manager, Regulatory & Quality Affairs Resume Examples & Samples

Participate and contribute in shaping the overall direction of the ANZ business and work in partnership with the ANZ LT and staff on strategically developing the business for the long term
Assume overall ANZ responsibility for RA / QA activities, develop business awareness and disciplines and provide support and advice in conjunction with the US, International and Regional RA / QA teams
Interface with local regulatory authorities in areas impacting regulatory compliance as Hologic regulatory representative
Train, reinforce and coach function teams on compliance requirements, procedures and practices
Complete health hazard assessments for regulatory reporting of product problems; prepare and submit regulatory agency information packages
Ensure related recall or field actions implemented and on time communicated with relevant authorities
Interact with regulatory agencies and relevant trade associations and KOLs
Mentor junior members of the department
Plan strategically to ensure the department has the capability to grow with and to support the business in to the future
Understand the industry advertising and promotional guidelines/codes for both professional and lay audiences to approve all ANZ marketing-related initiatives and collateral
Actively participate in USA, Regional and ANZ business leadership teams, RA & QA teams and work groups
Assist in hosting inspections, as needed
8-10 years of related experience
Experience interfacing with TGA in issues related to product compliance/field actions

Manager, Regulatory Accounting Support Resume Examples & Samples

Responsible for supporting and managing utility specific regulatory issues and requirements
Responsible for drafting or reviewing technical memoranda providing the accounting analysis of electric and gas rate orders
Partners with Regulatory to operationalize requirements for consistent processes
Responsible for maintaining compliance to regulatory data request responses
Reviews financial reports and advises on entry bookings and identifies regulation implications from reports
Leads regulatory asset / liability calculations and the maintenance of the general ledger
Analyses deferral variances found by working with financial accounting
Responsible for certifying regulatory assets, liabilities and footnotes
Oversees the maintenance and updates for the asset and liability catalogue to ensure appropriate treatments based on rate case
Provides utility industry specific counsel to employees, manages third party consultants and contractors, and advises senior leaders as necessary
Builds and manages results-driven teams by taking a strategic and technical view of performance management by involving employees in planning, relationship building, decision-making, forecasting, and analysis processes
Ensures proper support to meet business requirements of financial and non-financial controls
Regulatory compliance
Utility transmission application
Regulatory laws
Bulk power supply system
Network operations
Governance processes
Process identification
US GAAP, Sarbanes-Oxley, SEC regulations and IFRS
Bachelor’s Degree, Master’s Degree preferred 7 years in Accounting with increasing responsibility
Demonstrated ability to support regulatory processes
Experience working with regulators
Background in utility service or similar industry accounting
Ability to address regulatory risks and implement processes
Ability to meet deadlines with competing priorities
Effective collaboration and partnership capabilities
Excellent written / oral communication skills and follow-up

Manager, Regulatory Engineering Resume Examples & Samples

Working with the legal/regulatory team to identify relevant global or local standards and/or approvals required on a per airline program basis
Building plans to demonstrate compliance and secure approvals in a cost- and time-efficient manner, including consideration of any applicable precedents
Interfacing with internal subject matter experts on document compilation or test plan execution in support of license applications or demonstrations of compliance
Working with in-country third party representatives to understand the regulatory landscape and coordinate the application process when necessary
Assessing project scope, setting project cost, risk, and timeline expectations for leadership and program teams, and managing delivery against these expectations
Minimum of seven years’ experience in a wireless telecommunications radio compliance regulatory role with international scope,
Ability to interpret regulations, provide guidance, and represent Gogo’s interests to external authorities, even in situations where no uniform guidance or precedent is present,
Demonstrated effectiveness working in an international context, and availability to travel accordingly when necessary,
Prior experience with avionics, particularly related to commercial air transport, highly desirable,
Technical depth in radio frequency engineering, electromagnetic compatibility, and similar disciplines sufficient to communicate in detail with subject matter experts, assess possible courses of action, and make recommendations,
Ability to concisely summarize complex scenarios, and effectively communicate status and recommendations to the wider organization,
BS in Electrical Engineering or related discipline. MS preferred
Legal experience preferred, but not required

Manager Regulatory & Start Resume Examples & Samples

Provide Proposal Management with input on proposals and budget development for RSU component of projects. Attend proposal defences as needed
Resource employees efficiently to ensure achievement of utilisation and realisation targets
Review and analyse performance metrics and processes to provide input in the development and implementation of process/system improvements
Support employee efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines
Manage employees in accordance with organization’s policies and applicable laws. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions for all management / human resource matters
Mentor employee and ensure adherence to project timelines, scope of work and budget
Serve as lead for single projects or programs as necessary
Serve as advisor for designated clients as necessary. Provide RSU oversight across protocols / programmes. Serve as point of contact for issue escalation and process alignment
Participate in the selection and on-boarding process for new RSU employees by conducting candidate review and participating in the interview process. Ensure employees have the appropriate materials, systems access and training to complete job responsibilities
Support team to ensure that they successfully complete mandatory Compliance and GCP training and pass related exams
Full knowledge of drug development process
Full knowledge of applicable regulatory requirements, SOPs, and company’s Corporate Standards
Strong knowledge of budget management and resourcing
Strong working knowledge of medical terminology
Strong knowledge of Microsoft Office and e-mail applications
Ability to independently coordinate and manage new processes
Ability to lead and motivate teams
Ability to work well within a matrix team environment
Fluent Swedish language skills and very good English language skills

Compliance Manager, Regulatory Services Resume Examples & Samples

Ability to interact with Business Development to foster increased food contact business with both existing and new clients
BS/MS/PhD Degree in a scientific discipline
Minimum 5 - 10 years of experience in Chemical Industry
Experience in communication with the FDA –Office of Food Safety and Applied Nutrition (CFSAN)
Experience in understanding of chemical regulations in the US

Manager Regulatory Programs Sustainment Resume Examples & Samples

Operate with high degree of independence and requires sound judgment and discretion in reporting or escalating complex and sensitive issues to senior management in different countries and IB Toronto
Work in an unstructured environment and outside the scope of manual guidelines/prescribed routines
Prioritize demanding activities, keeping the Director and other members of Senior Management informed of significant developments, progress and results

Manager, Regulatory Safety Affairs Resume Examples & Samples

Focus on on-road motorcycle and automotive product lines
Sensing and reporting on emerging safety regulations, standards and compliance test requirements
Work with related government agencies to guide Honda’s safety policy
Honda representative for automotive industry standards-making committees and relevant compliance testing
Plan and support Honda safety performance assessment by 3rd parties
Assist HNA and Certification with relevant summaries of future regulations
BS Degree -Mechanical Engineering (preferred) or comparable work experience
15+ years in transportation industry or regulatory compliance-related area
Understanding of mechanical engineering concepts (required)
Familiar with product liability issues and product safety regulations (strongly preferred)
Strong communication (written and oral) and presentation skills (required)
12+ years’ experience writing communications related to transportation industry, government relations or corporate communications
Honda knowledge and experience (strongly preferred)
Ability to manage a variety of tasks without direct supervision
Excellent theoretical and practical understanding of automotive equipment and technology
Strong analytical and problem-solving skills (required)
Knowledge of Honda product lines (required)
Familiar with competitor products (a plus)
Sufficient operational skill to use and understand practical use of all Honda product lines (esp. automotive) and make an adequate evaluation of future safety and compliance regulatory issues
Organized, through and detail-oriented
Moderate travel required

Project Manager, Regulatory & Control Resume Examples & Samples

Coordinate Business Change Committee meetings facilitation and follow ups: scheduling, agendas, escalations, preparatory meetings
Draft Business Change Committee Meeting Minutes and upload to BCC SharePoint
Manage Business Change Committee Documentation and Reporting
Lead updates to Business Change Committee procedure and document templates
Create monthly Business Change Committee Executive Summary
Be accountable for monthly reports: Lessons Learned and Testing Issues Log
Update Business Change Committee Charter and Lifecycle as needed
Maintain Business Change Committee SharePoint Site
Create Project Folders and grant site permissions for Business Change Committee SharePoint
Update and validate Business Change Committee Project folder fields
3 to 5 years’ experience, financial services preferred
Ability to work with cross functional teams

GIS Business Manager Regulatory Engagement Resume Examples & Samples

The Business Manager – Regulatory Engagement is responsible for supporting an effective internal programme to ensure that Barclays is seen by global regulators to be meeting or exceeding their expectations for the effectiveness and responsiveness of our Cyber Security controls
This is a key role within the GIS Chief of Staff office. The successful candidate will have a proven track record of delivery and engagement at all levels of global organisations
Delivers against the agreed strategy for GIS regulatory engagement globally
Develops the GIS response to all regulatory requests for information and meetings, shaping the response and providing governance and internal review
Responsible for delivering position papers on regulatory policies and statements, identifying impact to Barclays cyber security strategy
Conducts gap assessments and high-level compliance assessments against regulatory standards and preferred governance frameworks
Acts as an escalation point for notification to the regulators of significant events within Barclays
Supports management of GIS regulatory interactions to ensure an effective relationship with all relevant regulatory bodies globally
Supports a virtual team of global contacts to support in-country regulatory relations and activity
Develop an effective working relationship with the Regulatory Relations team and other key governance stakeholders
Tracks progress of all activity associated with commitments made to regulators, ensuring there is a clear plan for delivery and escalating issues as needed
Regularly meets with key management who own regulatory actions (both inside and outside of GIS) to ensure that we are meeting both the letter and spirit of regulatory commitments, and that any reporting made is accurate and realistic
Report to key governance forums on GIS ability to meet regulatory expectations an specific commitments
Demonstrable experience covering all aspects of regulatory engagement
Strong people management skills – experience working in a matrix management model and with virtual teams
Good influencing, challenging and negotiating skills
Experience of strategic consulting engagement approaches
Ability to negotiate and solicit engagement at all levels of the organisation, and strong experience of working with senior stakeholders (up to MD level)
Action-oriented with a focus on continuous improvement in all areas of responsibility
Capable of working autonomously to deliver high quality, complete deliverables
Effectively and concisely communicate key issues and ideas
Proven competency in advanced use of MS Office applications, specifically PowerPoint, Excel and SharePoint
Experience of working within regulated industries and of working with regulators
Applies internal and external knowledge and experience when assessing needs/solutions
Proven track record of working in the Financial Services Industry
Preferably have a working knowledge of Barclays – goals, financials, staff numbers and structure
Experienced at implementing or managing risk management processes and tools; actively seeks ways to understand, mitigate or reduce risks, drawing on expert advice, risk assessment, and management reports
Understand own learning style; learns from mistakes or successes for future planning and development; Familiar with journals and material relevant to specialty and industry
Proven track record of personal and professional achievements
Fully compliant with all of the Barclays Values

Drug Safety Manager Regulatory Intelligence Resume Examples & Samples

Oversight of collection, verification and updates of the safety regulatory reporting intelligence in Clinical Trials, Post Marketing and Device environment
Implementation and improvement of processes for handling regulatory intelligence
Communication with Competent Authorities and Ethic Committees globally
Development of KPI for safety Reporting intel
Business Development of Safety Intel and PV services
Project Management of PV projects
Line Management of Regulatory Intelligence Team
Previous interaction with Competent Authorities including Inspection environment
Solid experience with various aspects of Pharmacovigilance
Previous line management experience

Senior Program Manager Regulatory Reform Resume Examples & Samples

Owner of Covered Funds mandates, control process and compliance as they pertain to all businesses across Citigroup
Accountability for proprietary trading mandates and compliance specific desk/business unit(s) while ensuring, accuracy, completeness while simultaneously acquiring business/risk/legal consensus as applicable to the Volcker Rule
Project Manager for specific strategic actions outlined by ICG management as it pertains to Volcker compliance

Manager, Regulatory Supervision Resume Examples & Samples

Assisting in the creation, revision, and communication of procedures and other tools to reinforce compliance in Distribution and Product Management for business information security, business continuation, records management, privacy, and other compliance related topics
Reviewing regulatory alerts, action plan creation, and implementation
Managing projects including the identification of resources and ensuring business needs are met. This would include leading teams, meetings, and collaborating with business partners
Providing training, as necessary to ensure proper understanding and utilization of compliance procedures
Driving continuous process improvement (e.g. efficiencies, controls, governance) in partnership with internal stakeholders and the Director of Operations & Controls
3 - 5 years experience in one or more of the following disciplines: audit, system audit/application development, operations management, risk management, process management, or other control type functions
Compliance, or risk background preferred
Experience in developing procedures and completing risk assessments
Ability to work individually and demonstrate drive, persistence, and personal ownership of assignments
Ability to work in teams and actively participate in making decisions and show problem-solving capabilities
Possess excellent analytical and organizational skills
Excellent communication, presentation and facilitation skills
Proficiency in Excel, Word, and Powerpoint

Delivery Manager Regulatory Ops Resume Examples & Samples

Primary point of contact for all operational activities (e.g., allocate and track publishing, GEM operational activities, formats, templates,, technical requirements)
Oversee publishing deliverables on a day to day basis to ensure successful execution of operational activities for assigned products
Coordinates and tracks delivery of required content with content owners for routine / maintenance submissions in all markets
Assist functional leadership to assess performance of activities against defined targets (e.g., collect and measure KPIs, performance metrics data)
Driver of quality of submission build, creation of submission standards and ensure vendor compliance with standards. Responsible for understanding and communicating impact of Industry changes relevant to submission sciences, and driving innovative process change for improved efficiency
6 to 8+ years pharmaceutical and regulatory experience (biotech products preferred)
4 to 6+ years regulatory operations experience
Vendor management experience beneficial
SME in regulatory operations processes
Strong communication and project management abilities in global and virtual teams

Business Project Manager Regulatory Change Resume Examples & Samples

Understand regulatory requirements and UBS policies and how they apply to the different UBS locations and clients
Conduct workshops with business risk management, legal, front and operations representatives to develop feasible front-to-back solutions
Create business requirements and implementation proposals in close collaboration with IT, considering feasibility in terms of costs, delivery capacity and timelines and finally to gather all relevant sign-offs
Ensure successful implementation, including user-acceptance testing, end-user communication and rollout activities like conducting user trainings and creating manuals
Project management, including reporting on budgets, milestones, dependencies, issues, risks and mitigations

100

Manager, Regulatory Product Management Resume Examples & Samples

Regularly monitor external information sources for new proposed or enacted rules
Shape pending rules through representation of Prudential in industry trade groups. Actively participate in group activities and submission of commentary on regulatory/compliance proposals
Partner with internal stakeholders to determine the impact of rules to plan administration. Proactively drive the strategy for service model and product offering enhancements (new products, services, documents, interactive tools, etc.) by market and segment
Keep internal associates up-to-date on rules and related developments through timely internal memos, information sessions, Washington Update calls, etc. using language easily understood by the audience
Create and publish external communications (Pension Analysts, Bulletins, newsletter articles, etc.) for distribution to our clients and advisors that explain rules at an understandable level and provide insights on impacts to audience and Prudential’s expected handling
Support ad-hoc requests to provide guidance on general compliance/regulatory topics and supporting solutions to internal associates as needed
Support existing and new product offerings and enhancement opportunities through assessment of required changes, needs, or requests from plan sponsors, participants and internal partners. Findings can be used to influence the Product Development decisions
Minimum of 5 years of related experience in the financial services industry, preferably in retirement working with defined contribution, defined benefit, nonqualified and/or IRA products and services
Strong understanding of the needs of Corporate and Tax-Exempt and retail markets inclusive of Plan Sponsors, Advisors, and Participants
Ability to work independently on multiple assignments simultaneously
Ability to understand legislation and regulatory guidance, and determine its application to existing and potential clients
Understanding of current product offerings in order to identify changes needed as a result of legislative and regulatory actions as well as changing needs of plan sponsors and/or participants
Ability to communicate (both in writing and verbally) clearly and effectively to various levels of internal and external audiences, tailoring messages as appropriate
Ability to react quickly to a changing legislative and regulatory environment
Ability to effectively research various sources (hard copy publications, Internet, etc.) to respond to inquiries
Ability to think creatively and apply existing knowledge in new ways when identifying potential solutions to new situations
ASPPA and other accreditations are a plus
FINRA Series 6 & 63 licenses required within 120 days of hire

101

Manager, Regulatory Liaison Resume Examples & Samples

Create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team
Create and drive execution of regulatory strategy to support lifecycle management of in-line (i.e., mature) products
Occasionally review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues
Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label
Collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, MRL and across Divisions with GHH and MMD to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities
Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings and post filing activities
Participate in business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams
Act as the Global Regulatory Team (GRT) Lead for assigned products
May have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc
At least 4 years of relevant experience in the pharmaceutical industry, OR an M.S. or higher plus 2 years of relevant experience
Must have excellent communication skills (both oral and written)
Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects
Flexibility and negotiating skills are required
Strong scientific and analytical skills

102

Manager, Regulatory Records Resume Examples & Samples

Prioritizes work for the Regulatory Records team
Creates and maintains the document repository, scanning, and indexing for all study-related documents
Ensures that all applicable paperwork is completed upon release and return of each project document and/or project file from the Document Control Room/Trial Master File Room
Controls access to the Document Control Room/Trial Master File Room according to applicable SOPs/WIs
Bachelor Degree with courses in the scientific/regulatory field or equivalent related experience
Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology

103

Regulatory Accounting Manager Resume Examples & Samples

Interpret and apply GAAP and regulatory decisions in managing recording of transactions, documenting accounting policies, as well as providing accounting guidance to various operating units and assessing impact to the financial statements
Supervise month-end accounting for accruals, revenue entries, balancing accounts and other business-related activities such as fuel and purchased power transactions
Perform and oversee monthly variance analysis including identifying key drivers, reaching out to stakeholders, highlighting trends and analyzing causes of unexpected variances
Serves as a trusted accounting expert; possesses a solid understanding of generally accepted accounting principles and has the ability to determine and document appropriate accounting conclusions
Oversee and approve critical general ledger account reconciliations
Oversee the development and maintenance of accounting or financial models in support of financial and regulatory requirements
Perform quarterly and annual compliance reporting and support data request for various regulatory agencies
Support SCE’s financial reporting disclosure (10-Q/10-K) and MD&A requirements
Oversees hiring and performance management, balances work across individual contributors, and participates in salary planning and talent development planning
Reviews individual contributors’ work for accuracy and value to operational decision making, ensuring timely delivery
Uses goal performance and accounting information to inform decision making and identify opportunities and risks relevant across the Controller’s Department
Communicates opportunities, risks and associated resolution, recommendations for goals, and shares best practices and critical findings with other leads
Knowledge of SEC Reporting requirements
Experience with SOX governance
Demonstrated experience in effectively communicating (written and verbal) accounting matters, effective decision making, and results delivery
Strong interpersonal and cross-organizational communication skills, including the ability to work with all levels within the company
Demonstrated strong ethics, influence and negotiation, leadership, interpersonal skills, communication, accountability and ownership, and organizational skills. Demonstrated ability to effectively manage multiple concurrent tasks in periods of tight deadlines and to engage in continuous learning
Demonstrated ability to follow Edison safety protocols and safe work practices

104

Regulatory Consulting Manager Resume Examples & Samples

Bachelor's degree required, emphasis in accounting, economics or finance preferred
Minimum of 5 years of experience in telecommunications regulatory reporting and/or accounting
Strong accounting skills required

105

Manager, Regulatory Professional Resume Examples & Samples

Ensure submission-readiness of all regulatory documents
Basic Qualifications: Bachelor’s degree and 2 years of regulatory/drug development experience
Good communication skills – both oral and written
Organizational skills – detail oriented and can deal with frequent changes in product activity
Strong knowledge of eCTD elements and structure
Strong team player that has a customer service approach and is solution oriented
Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
Expertise with templates and formatting tools
High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
Willingness to think outside of the box and adapt best practices to our small, but growing environment
Ability to adapt in a constantly evolving environment
Self-motivated with a strong sense of ownership in areas of responsibility
High degree of professionalism, ethics and integrity
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

106

VP & General Manager, Regulatory Sciences Resume Examples & Samples

Recognized as a drug, biologic or medical device scientific expert with specific expertise in regulatory affairs, clinical, nonclinical, or chemistry manufacturing controls
Deep knowledge of the drug, biologic or medical device development process
Collaborate with the Specialty Solutions business development team to identify and drive expansion opportunities globally; participate in and lead client interactions, serving as a Subject Matter Expert when securing new business
Ability to excel in a matrixed management environment; communicate regularly with internal executive teams
Effectively lead, mentor and develop staff; build relationships across the business to maintain and enhance employee engagement and office culture
Maximize customer value and satisfaction by aligning complex solutions and service to key customer initiatives
Provide strategy to product development plans and requirements, including gap analyses, scientific and regulatory strategies and project outlines and timelines
Interact with U.S. and foreign regulatory authorities and attend formal meetings when expert product development input is required
Define problems, collect and interpret data, draw valid scientific conclusions and propose solutions with respect to product development activities
Partner with colleagues, clients, physicians, scientists and biopharmaceutical development professionals to drive projects to completion
Demonstrate deep customer expertise; collaborate with appropriate parties to identify the drivers leading to business success
Scientific degree/credentials with emphasis in regulatory, clinical, nonclinical or chemistry manufacturing and controls; advanced degree desired; PhD strongly desired
Deep understanding of biopharmaceutical or medical device product development
At least 10 years of full life-cycle biopharmaceutical and/or medical device development experience within a professional services model
Successful experience managing a business unit with complete profit and loss accountability; experience participating in or leading merger and acquisition activities
Thorough understanding of drug development, clinical study design, regulations and scientific principles
Understanding of medical terminology and statistical methods
Experience interacting directly with regulatory agencies and managing the preparation of regulatory dossiers
Strong command of the English language, grammar, style and logical progression; ability to write in a clear, concise and persuasive manner
Demonstrated leadership and communication skills; organized and self-motivated
High attention to detail and ability to detect inconsistencies

107

Manager Regulatory Market Access Resume Examples & Samples

In partnership with development engineering and product line management, this role is responsible to provide guidance for product design and country regulatory approval of FlytLIVE Connectivity products and services
Communicating with regulatory and certification agencies regarding pre-submission strategies, potential regulatory pathways, compliance testing requirements, or clarification and follow-up of submissions under review
Interfacing with internal Thales subject matter experts, stake holder groups on regulatory compliance, document compilation or test plan execution in support of license applications or demonstrations of compliance. In addition, working with in-country, third party representatives to understand the regulatory landscape
Advise management on necessary regulatory and policy changes and ensures compliance with National and ITU rules and processes. Advocates for regulatory policy change as well as in advancing company specific initiatives with the FCC and other International Administrations in the areas of Earth Stations Aboard Aircraft (ESAA) and SATCOM
Contribute to Thales company efforts at regulatory groups, trade associations or other multi-party organizations to advocate for policy or regulation changes with regulators around the world
Providing technical review of data on reports that will be incorporated into regulatory submissions to assure rigor, accuracy, and clarity of presentation. In addition, preparing or maintaining technical files as necessary to obtain and sustain product and service approvals
Preparing or directing the preparation of additional information or responses as requested by regulatory agencies
Tracking and interpreting regulatory rules or rule changes and ensuring that they are communicated to relevant stakeholders
Obtaining, distributing and maintaining updated knowledge base of existing and emerging regulations, standards, or guidance documents
Bachelor’s degree preferably in Engineering (telecommunications, electrical, industrial, aerospace,) or related science
8 + years telecommunications regulatory compliance including global regulatory issues and licensing
International work experience and being fluent in English is required
Demonstrated ability to communicate and partner with all internal Thales teams involved in the regulatory compliance process
High level of expertise with regulatory and certifications agencies, 3rd party services and customers
Specific experience in filing and coordinating spectrum with the ITU/FCC. Experience with the ITU rules and process for driving necessary regulatory changes or ensuring compliance
An MBA or Masters is a plus
12+ years of combined, related work experience in the federal government or in the private sector for a ESAA, Satellite technology or telecommunication company (a combination of the two is preferable)
Strong stakeholder management; Strong working knowledge of telecommunications and the respective approaches of operators and administrations globally in the Ka, Ku, and L- frequencies is essential
Understanding of future satellite and terrestrial spectrum plans in the Americas and EU is highly desired
Understanding of regulatory compliance audits
Innovative problem solver and key project leader

108

Manager, Regulatory & Start Resume Examples & Samples

Provide Proposal Management with input on proposals and budget development for RSU component of projects. Attend proposal defenses as needed
Where applicable, review and ensure project instructions for RSU projects are complete and accurate, including local requirements as appropriate. Provide feedback to employees in the writing of project work instructions
Resource employees efficiently to ensure achievement of utilization and realization targets

109

Manager, Regulatory Resume Examples & Samples

Identify and review the compliance requirements with regard to mobile finance and remittance
Identify and develop risk assessment for AML CFT and associated compliance requirements
Review and recommend the necessary control activities, policies, strategies and mitigation(s) including system requirements, policies in relation to staff on-boarding, customer due diligence, screenings, transaction monitoring, high risk categories of customers and /or partners, onboarding of merchants etc
Assist in any audits or investigations [internal or external] of any suspicious activities
Conduct AML CFT training for staff
Make recommendations in relation to outcomes of screenings and /or checks, including possible associations with sanctioned entities
Carry out testing of the control activities including testing of systems
Review any new business activities and ensure the AML CFT and associated compliance requirements are catered for
Review ongoing changes in the AML CFT and associated compliance requirements / regulations and to carry out gap assessments as well as recommend controls
Communicate/liaise with other stakeholders to coordinate activities (e.g, processing of information required by regulators, developing policies and procedures in response to regulatory requirements) for the purpose of encouraging effective and efficient management
Submit compliance plans to the Management as required
Advise the Management of emerging compliance issues and
Act as central point of contact between the entity and the regulator and relevant authorities during for general regulatory requirements
Degree in the relevant discipline
At least 5 years of AML/CFT experience with exposure to financial institutions (particularly in the areas of cross border remittance services)
Strong understanding of AML/CFT requirements and securities regulations; relevant experience in an area involving AML/CFT & securities requirements
Excellent analytical skills with clear and logical thought process
Professional certification such as CAMS (Certified Anti Money Laundering Specialist) or equivalent will be advantageous

110

Manager, Regulatory Strategy & Consulting Resume Examples & Samples

Degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field
Moderate pharmaceutical/medical device related experience
Moderate experience in regulatory
Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, CTA, MAA, and CTD, including electronic submissions
Comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development
Excellent customer service and interpersonal skills, with the ability to work both as a team member and independently
Good initiative, adaptability, and pro-activity
Good attention to detail, flexibility, and open to suggestions

111

Regulatory Submission Manager Resume Examples & Samples

Work independently with project teams to design and execute high quality submission plans, ensuring the timelines and requirements are mutually understood and in line with Shire and health authority standards
Ensure GRO delivers high quality, compliant submissions to global health authorities within required timeframes
Work with GRO submission teams to effectively forecast and manage project specific resources, utilizing flexible resourcing and global load sharing in a matrix environment
Maintain a fluency in use of electronic and paper publishing systems and tools and global submission formats, with hands on publishing when required
Define and implement regional and global processes for paper and electronic submission publishing, including the evaluation of current processes
Interpret regulatory guidelines to produce regulatory submission business requirements and ensure that those requirements are implemented where appropriate at local level
Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved
Operate as Subject Matter Expert in dossier types, processes and/or technical solutions, with responsibility for training and mentoring fellow colleagues
Responsible for the review of R&D documents to ensure compliance with Shire’s submission ready standards guidelines
Lead and contribute to new and updated process and standards
Responsible for the accuracy of information for submission metrics and registration information for senior management
Lead and/or participate in GRA special initiatives
Management of vendor resources, when applicable
Minimum 5 years of pharmaceutical experience in a global regulatory environment, including experience with document management technology and electronic publishing software (e.g. Documentum, FirstDocs, ISI Toolbox, eCTDXpress, etc.)
5+ years of project management experience
Proficiency in publishing paper, NeES, and eCTD submissions and using related tools
Self-starter, who motivates, has tact, diplomacy, leadership skills and a flexible and positive approach
Demonstrated leadership ability, with strong negotiating and influencing skills
Ability to manage complex projects and timelines in a matrix team environment
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization
Understanding of Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines

112

Manager, Regulatory Reconciliation Resume Examples & Samples

Assist Operations with effective and efficient design and execution of control processes
Assist with the identification and reporting of metrics associated with the Operations control processes and key risks
Provide assurance over Operations control processes through periodic spot checks and audits
Serve as a resource and liaison for auditors and examiners
Performs human resource management activities, including identifying performance problems and developing plans for remedial action; evaluating performance; and interviewing and selecting staff
Establishes objectives and develops processes and procedures to ensure efficient and timely work flow
Ensures primary and secondary controls are reviewed and tested as appropriate to provide due diligence in compliance with organizational policies for risk management
Prepares and communicates recommendations for strengthening controls and assists management in developing action plans to address control weaknesses
Prepares written reports and delivers oral presentations to internal customers and management
Advanced concepts, practices and procedures of operational and regulatory auditing
Advanced investment concepts, practices and procedures used in the securities industry
Principles of banking and finance and securities industry operations
Developing processes and procedures for efficient and timely work flow
Promoting effective coordination between multiple work groups and functional areas
Establishing control mechanisms
Identifying and documenting risk management issues
Operating standard office equipment and using required software application to produce correspondence, reports, electronic communication, spreadsheets, and databases
Maintain currency in operational and regulatory processes and procedures
Read, interpret and apply information from business periodicals and professional journals

113

Internal Audit Manager Regulatory & Consumer Compliance Resume Examples & Samples

Manage the audit services for regulatory compliance, including credit consumer compliance regulations and safety and soundness for credit cards and deposit functions
Anticipate the impact of new regulations or rulings and review appropriate organizational responses. Provide (if licensed) independent legal counsel on laws and regulations to Internal Audit as they relate to the performance of regulatory reviews
Build effective business partnerships with key leaders at both the Bank and Corporate, while maintaining independence and objectivity
Coordinate activities with the Legal and Compliance department regarding monitoring of regulatory compliance
Manage and perform audit procedures, including developing objectives and criteria, interviewing business owners, documenting business processes and procedures, gathering and analyzing sufficient evidence, identifying and defining audit observations, and communicating results
Supervise staff members, coach them on technical auditing skills, review their work, assist them in creating their development plans, write their performance reviews, and manage them to provide exemplary results
Prepare and occasionally present Audit Committee meeting materials such as summarizing audits completed, risk assessment results, or special presentations on topics of interest to the Committee
Coordinate activities with and assist Nordstrom Inc. Internal Auditors, regulatory examiners and external auditors as appropriate
Assist with maintaining the department budget and other management duties
Bachelor’s degree in Business, Accounting or Finance together with one or more of the following additional accreditations is required: advanced degrees such as an MBA or JD; certifications such as the Certified Public Accountant (CPA), Certified Information Systems Auditor (CISA), Certified Internal Auditor (CIA), and Certified Information Systems Security Professional (CISSP). Licensed attorney preferred
Certification in regulatory compliance is preferred
Minimum of 5 years of experience, including 3 years in a managerial role in the financial services industry is required. Credit card issuer industry experience is preferred
In-depth knowledge of Office of the Comptroller of the Currency regulatory examination procedures for credit consumer compliance and safety and soundness is required. Experience with the OCC in a credit card issuing bank is preferred
Mastery of the Institute of Internal Auditors International Standards is preferred
Proficiency with Microsoft (MS) Office programs and PC tools is required. Proficiency with specialized audit software, Audit Command Language (ACL) or other data analysis tools and PWC Team Mate is preferred
In-depth knowledge of internal control frameworks, risk assessment tools and techniques, and business process analysis

114

Regulatory Product Manager Resume Examples & Samples

Plan and manage global regulatory readiness campaign
Monitor and manage cost recovery programme
Regulatory research and management of regulatory collateral
Internal training and communications
Support and collateral for client and media engagement
Annual planning and funding for regulatory projects
Coordination with other LoBs and marketing

115

Manager, Regulatory Resume Examples & Samples

Manages supervisors regional regulatory and clinical associates
Directs, manages resources to implement tactical business plans and programs/ projects
Develops, implements solutions to department issues
Bachelors Degree required; Master Degree desired University plus directly relevant experience as a manager, supervisor and relevant regulatory experience as an individual contributor

116

Manager, Regulatory Publishing Resume Examples & Samples

Manage all publishing activities for the Regulatory Affairs Group
Train and mentor publishing staff
Responsible for oversight of the publishing team and performance on compilation and publishing of submissions
Able to review and publish fully QC compliant reports and regulatory submissions using the relevant publishing software and tools
Responsible for staying abreast of US, Harmonized (ICH) eCTD, and ex-US guidances and requirements to support regulatory submissions (e.g., INDs, IMPDs, CTAs, NDAs/BLAs/ MAAs)
Effectively forecast and manage project specific resources to deliver high quality compliant submissions within required timeframes
Directly liaise with sponsors or project teams for planning and delivery of publishing activities
Act as a resource for technical knowledge of publishing activities for both clients and associates; is able to troubleshoot and resolve publishing technical issues
Identify and evaluate publishing tools to facilitate effective completion of projects and ensure publishing output continues to meet regulatory and industry standards
Responsible for quality systems for publishing, including the generation of globally applicable Standard Operating Procedures (SOPs) and Work Instructions
Maintain improvement efforts to increase overall operational excellence and efficiency
Responsible for business development and providing budget costing for the publishing portions of both multi-service and regulatory stand-alone projects

117

Manager, Regulatory Resume Examples & Samples

Prepares ANDAs, INDs, NDAs, Amendments, Supplements and Annual Reports for FDA submission. Reviews submissions prepared by direct report. Represents Regulatory Affairs and provides regulatory support to the R&D/relaunch teams and other teams, as necessary
Liaises with FDA on regulatory submissions and negotiates approvals
Interacts effectively with functional business units to secure acceptable documentation re-quired for submissions. Analyzes documentation for accuracy and compliance with current regulations and FDA guidance
Resolves issues with regulatory submissions
Evaluates changes to regulatory documents via the change control process. Familiarity with Trackwise and/or Documentum systems is a plus
Monitors and investigates daily federal register, FDA internet updates and trade press notices for changes in regulations or regulatory policy that may impact internal operations
Requires minimal supervision for most assignments
May Supervise Senior Associate. Major Accountabilities
Adheres to all applicable procedures, cGMPs, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.)
Ensures all work is performed in a safe, effective manner, and in compliance with the appro-priate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals

118

Regulatory Advisory & Relations Manager Resume Examples & Samples

Strategically manage meetings between UBS subject matter experts and supervisors including preparing UBS management for the meetings, recording key issues and outcomes and ensuring actions are addressed promptly and clearly
Collaborate with other global regulatory managers, including analyzing developments across jurisdictions to ensure consistency of approach and reporting on US aspects of relevant developments for global meetings and reports
Pro-actively identify trends in regulatory requests and discussions and raise them to senior regional and business management to ensure strategic responses
Prepare briefings for and brief senior management for regular and ad hoc meetings with key supervisors
Extensive interactions with regulators and / or audit staff on a range of supervisory topics

119

Manager, Regulatory Submissions Resume Examples & Samples

Excellent communication skills, organization and planning skills and attention to detail
Direct supervisory and project management skills and ability to work independently
At least 5 years experience in the pharmaceutical industry with 3 years preferably in Regulatory Affairs or possibly in Drug Development

120

Manager Regulatory Development Resume Examples & Samples

Product Development Activities – 40% of allocated time
Regulatory Activities
At least 5 years of experience in regulatory affairs, as a project leader or in another related position and extensive knowledge of the regulatory environment
Leadership and building effective teams
Strategic agility
Strong Project Management Skills
Good risk analysis skills
MS Outlook, PowerPoint, Word, Excel, WordPerfect, MS Project, Adobe Suite

121

Manager, Regulatory Coordination Operations Resume Examples & Samples

Develop relationships with stakeholders from across the enterprise to establish standardized reporting regarding regulatory findings and observations, as well as determine guidelines for the management of ad hoc reporting requests
Develop & maintain appropriate reporting to the Board, senior management, and regulatory agencies relating to regulatory findings
Work cross-functionally to design and build system requirements, including the development of system requirements for Archer & Accelus
Implement a proactive monthly oversight process to ensure compliance with regulatory due dates and the management of extension requests from action plan owners, reaching out to regulatory agencies as necessary
Communicate with regulatory agencies regarding completed validation of regulatory and enforcement action findings to regulatory agencies
Maintain metrics regarding business unit responsiveness to regulatory findings
Manage increased volume of continuous monitoring & ad hoc requests, establishing official process and working with regulators and business units to complete requests
Create and manage Reg Relations Dashboard process, ensuring team is meeting SLAs and inclusive of the development of metrics against team processes (meetings, turnaround times, etc.)
Strong written & presentation skills
Strong people leadership skills
Detailed and task orientated, ability to manage complex projects
Experience in Compliance, Banking or Financial Services
Strong communication skills and the ability to communicate effectively with senior and executive management
Ability to demonstrate flexibility in a fast-paced ever changing regulatory environment
Experience with Microsoft Office Suite (Access, Excel, Word, Powerpoint, Sharepoint)
Bachelor’s Degree required, Master’s Degree and CRCM certification preferred
7-10 years Compliance, Banking, Financial Services or other related business experience

122

Project Manager Regulatory & Control Resume Examples & Samples

Coordinate teams on exams, audits and compliance testing to support internal and external deliverables
Communicate with project team leads on specific areas of responsibility
Assess and ensure that client and franchise impacts relating to regulatory environment are communicated and managed in partnership with Legal, Compliance, Regulatory Relations, Operations, Risk, AML, Community Development, Corporate Communications and Client Experience
Collaborate with banking product development and segment teams to ensure understanding of regulatory impacts to consumers and their products
Maintain complete documentation and secure artifacts necessary to close out regulatory issues and corrective action plans
Support Management Control Assessment (MCA) and Annual Risk Assessment efforts for the Banking Products team, including oversight and adherence to established product policies and quarterly management reporting
Strong computer skills: MS Word, Power Point, Excel, SharePoint, Visio

123

Regulatory Developments Manager Resume Examples & Samples

Identify emerging UK and EU regulatory developments
Assess the impact of emerging UK and EU regulatory developments on the business
Ensure emerging UK and EU regulatory developments are communicated to the business including both the Compliance and Risk teams
Review implications of UK and EU regulatory developments for Regional strategy and risk appetite, engaging with other EU Aviva Investors 2nd line business units, as appropriate
Responsible for the collation, drafting and submission of Aviva Investors’ responses to UK and EU policy makers and trade associations; working closely with Aviva Group to co-ordinate such responses where relevant
Provide challenge to 1st line business unit’s response to regulatory developments
Liaise with Group 2nd line and other 2nd line Aviva business units to ensure co-ordination of consistent responses to regulatory developments and group positions/strategy are taken into account in relation to material developments
Liaise with the other global Aviva Investors 2nd line business units to assess wider implications from regulatory developments
Identify and analyse actual UK and EU regulatory change and provide expert advice and guidance to the Business on implementation
Act as Subject Matter Expert for regulatory implementation projects, and provide assistance and steer to the 1st line business unit’s implementation of UK and EU regulatory change requirements
Provide training to Aviva Investors staff on UK and EU regulatory developments
Develop relationships with regulatory and trade bodies and other industry contacts in order to increase influencing capability
Assist the wider UK & EMEA advisory teams on relevant projects as required
Emerging UK and EU regulatory risks should be communicated to the 1st line business units and, if appropriate, escalated to management and Group Regulatory Risk in a timely manner
Influence business change as a result of UK and EU regulatory and any other relevant external industry developments
Contribute to regular reports as necessary
Qualified to graduate level Minimum of 2.1 or equivalent
IMC
In-depth technical knowledge of current UK and EU regulatory developments
Excellent in-depth technical knowledge of the UK Regulatory Regime
Ability to interpret regulatory drafting
Understanding of EU and legislative process
Become knowledgeable of Aviva Investors’ businesses
Very strong written and verbal communicator
Excellent influencing/negotiation skills
Good experience of providing advice within an asset management organisation
Significant involvement with regulatory issues affecting asset management business

124

Risk Manager, Regulatory Security Risk Resume Examples & Samples

Establishes credibility and maintains strong working relationships with groups involved with payment security and compliance matters (InfoSec, Legal, Business Development, Internal Audit, Fraud, Physical Security, Developer Community, Networking, Systems, etc.)
Responsible for building and influencing payment security as a core competency throughout our relationships with our internal teams/partners/vendor; this includes providing education and training to the organization and industry forums
Responsible for defining, documenting and mapping relevant regulatory payment security frameworks to internal business processes
Responsible for continual process improvement and innovation in payment security assessment process, control documentation, and enabling business teams to be on time, on budget, and on quality
Delivers recommendations and risk interpretations in a clear, concise and audience-specific format
Responsible for conducting internal risk investigations and assessments
Bachelors degree in Management Information Systems, Computer Science or relevant field, Masters Degree preferred
Minimum 6-years of information security, payments, audit, risk management or related client service or consulting experience
Technical knowledge and familiarity with all payment security standards
Experience in analyzing large data sets
Related payment security control and compliance experience in various frameworks including: PCI DSS, PCI PA-DSS, PCI PTS, GLBA, ISO, NIST, etc

125

Manager Regulatory Research & Insights Resume Examples & Samples

Developing new and improved methods for gathering regulatory intelligence to inform company strategies, policy positions, regulatory submissions, and other regulatory actions
Partnering with Regulatory Communications to create and deliver regulatory insights to internal stakeholders, including Altria Group and Operating Company (OpCo) leadership, Research & Development, Regulatory Affairs, External Affairs and others
Developing information and intelligence to support external engagement strategies, particularly with the public health and scientific communities
Implementing new tracking, monitoring and scanning tools to generate regulatory intelligence and information, including global scanning
Identifying emerging trends and providing summaries of potential business implications for the OpCos
Supporting Government Affairs strategies by developing information and intelligence to shape policy arguments, white papers, briefing materials, etc
Analyzing publicly-available and internal information to identify implications to OpCo product submissions strategies and develop related strategic recommendations
Bachelor’s degree or equivalent experience in a Science, Engineering, Operations, or Business Discipline
Advanced degree is preferred
10+ years of experience in FDA regulated fields and working knowledge of FDA CTP Regulations and Guidance Documents
Prior experience managing FDA product submissions for a regulated company or within a government regulatory agency such as the FDA
Strong ability to analyze complex information, distill insights and develop strategic recommendations. Ability to synthesize disparate and complex data/information to identify implications to strategies
Strong leadership and relationship management skills with proven ability to meet goals and timelines
Strong interpersonal/communication skills to interface with management and individuals at all levels of the organization
Ability to negotiate and influence at all levels of the organization
Strong presentation skills to clearly and articulately share project progress and developments

126

Manager, Regulatory CMC & Projects Resume Examples & Samples

7 plus years’ experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities. BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field)
Experience in pharmaceutical project management where CMC and / or manufacturing activity was the focus. Working knowledge of a wide variety of pharmaceutical dosage forms and processes
Experienced with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for IND/AR/CBE/PAS/NDA/BLA/ANDA submissions
Worked with multi-disciplined teams in the bio-pharmaceutical industry. Lead and managed regulatory CMC projects with internal and external partners
Worked with writing template tools, Documentum based or similar system #LI-SA

127

Manager, Regulatory Project Management Resume Examples & Samples

Works closely with the Global Regulatory Lead (GRL), as well as members of other Regulatory sub-groups, to direct the team through the process of developing regulatory strategy, and translates the strategy into an executable plan
Utilizes project management methodologies and tools to guide Regulatory teams in achieving operational excellence; driving teams to achieve clarity on issues, interfacing with management and supporting decision-making, while monitoring timelines. Acts as an expert in regulatory project management within the Takeda organization
Bachelor’s Degree in a science or business-related field
Substantial experience working within Regulatory Affairs with a fluent understanding of drug development
Significant pharmaceutical industry experience
Qualified project management experience
Ability to articulate and establish business processes
Experience multitasking in a dead-lined controlled and highly regulated environment
Proven ability to communicate clearly and present key information objectively
Degree in Regulatory Affairs or RA Certification
Change management experience/Six Sigma
Analytical and Problem Solving Skills -ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem. Excellent ability to understand complex issues and propose creative and achievable solutions
Communication Skills -ability to express one’s self clearly and concisely to customers over the phone or with others within team; documents issues and/or concerns concisely and comprehensively
Politically astute– and a confident and respectful motivator
Interpersonal Flexibility- ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Knowledge Sharing- ability to capture knowledge within the organization; improve solutions, processes and deliverables through use of information; improve information capital by contributing experience, theories, deliverables and models for others to use. Shares information with staff as confidentiality allows
Change Management –ability to identify, advocate and implement change positively for the organization. Demonstrates flexibility and the ability to accommodate change
Teamwork - the ability to work well in a highly cross-functional team environment
Leadership Skills - has the ability to lead and motivate team members, without direct line management responsibility. Develops, uses and shares knowledge and uses strong interpersonal skills to influence and guide others (both inside and outside the department) towards the accomplishment of Takeda’s goals and objectives
Strategic Approach - identifies, create and implement processes for Regulatory Project Management that satisfy business objects of Takeda globally
Presentation skills –create and deliver presentations with appropriate messaging and focused recommendations

128

Manager, Regulatory Programs Sustainment Resume Examples & Samples

Develop and coordinate the implementation of control and testing methodology. This includes assessment of required tests to ensure an efficient and coordinated testing schedule approach across all supported countries and business lines
Promote collaboration and integration of the controls & testing program as an essential part of the overall regulatory sustainment oversight program for the supported business lines
Drives the development and implementation of key metrics with ownership for providing value added insights towards monthly dashboard reports
Monitor actions plans for mitigating risks and escalate control breaches by keeping management informed of emerging issues and trends regarding the implementation of regulatory and operational risk management frameworks, programs and tools
Demonstrates strong knowledge of banking regulations and its impact across all business lines of Scotiabank and actively engages with local and IB compliance team to enhance overall regulatory compliance framework
Champion process re-engineering review to develop innovative approaches and tools to improve and promote operational efficiency and enhance regulatory compliance program/processes
Reviews regulatory publications to keep apprised of new regulatory; analyze complex or diverse information; collects and researches data and utilize complement data to design work flows and procedures
Develop training programs and communication plan to help EDDU to understand their roles and responsibilities, to bring awareness and understanding of compliance issues and be aware of upcoming changes in regulatory requirements and the Bank’s Operational Risks Programs
Act as a consultant and instructor in operational and regulatory risk matters to the supported EDDU
Act as liaison with the 2nd Line and 3rd Line to develop and implement regulatory compliance program/ processes to achieve balance between operational efficiency and regulatory compliance
Perform assessments of monitoring of High Risk Customers processes, and independent reviews as required by Business needs
Identifies opportunities to mitigate risks within the Division by recommending enhanced evaluations and processes, working in collaboration with subject matter experts across various Business Units
Performs ad-hoc analyses and reporting in support of Business needs or to support compliance with country regulatory requirements under the Director’s oversight
5+ years of financial services and management experience
Thorough knowledge of banking, operational risk, regulatory risk, compliance and regulatory requirements and internal control principles
Strong organizational skills in planning, scheduling, and the ability to prioritize and deal with workload to meet tight deadlines
Excellent written and oral communication skills, negotiation and analytical skills
Solid knowledge of operational and regulatory risk management as well as laws and regulations, including those relating to new products, programs and business initiatives
Strong analytical skills with the ability to articulate complex documents and material effectively to assimilate relevant and key information in a practical and coherent way
Ability to identify necessary consultative procedures and maintain a broad perspective of the long-term business strategies and management objectives of the Bank and its subsidiaries
Ability to gain confidence and cooperation of business units and 2nd line functions while still retaining the independence and willingness to point out weaknesses
Strong project management skills to lead or be a key champion in Operational and Regulatory projects and initiatives
Strong communication and presentation skills are essential to explain regulations and internal policy and procedure
Strong negotiation abilities, good analytical skills and sound judgment in providing Operational and Regulatory Risk Management guidelines
High standards of performance, confidentiality, integrity, timelines and efficiency must be maintained at all times
Maintains awareness of and actively engages in activities across all business lines. Understands regulatory perspective on risk
Bilingualism English/Spanish required

129

Manager, Regulatory Supervision Resume Examples & Samples

Providing support and/or responsible for items related to branch operational risk
Assist in policy and procedure amendments by providing feedback
Investigate or assist in more complex investigations and respond to issues, including verbal and written queries

130

Strategic Client Manager, Regulatory Records Resume Examples & Samples

BA/BS degree with courses in the scientific/regulatory field or equivalent related experience
Moderate experience in a clinical and/or medical environment that includes working with regulatory records
Experience of managing high level sponsors
Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology
Strong verbal, written, and organizational skills with a team-oriented approach. Proficiency in Microsoft Office Suite and email
Ability to handle multiple tasks to meet deadlines in a dynamic environment

131

Manager, Regulatory Document Content Resume Examples & Samples

Lead team of professional employees to produce regulatory filings consistent with the regulatory case management processes. Assist in articulating and achieving consensus on what the Company will request. Manage the work, resources, and processes need to draft complete regulatory filings needed to implement Xcel Energy’s major initiatives. Manage teams and staff to ensure projects are consistent with Xcel Energy priorities, are appropriately advocated before regulatory bodies, are timely, and fully comply with all filing requirements
Work collaboratively with others in the Department and other business groups to understand the facts of cases in order to develop key messages for filings. Determine organization and appropriate level of detail for the filing. Partner with Law to identify the appropriate standard of review for inclusion in filings and for assistance in creation of filings
Develop the advocacy (construct the supporting arguments) for requests. Identify and incorporate appropriate supporting charts, graphs and examples. Draft filings and testimony. Ensure a clear voice and appropriate tone in filings and testimony. Identify risks and likely discovery issues related to requests
Control the content of the document during interaction with the regulatory case management team and with the business units. Control the document to ensure efficient production. Ensure format and presentation consistent with company standards. Assist with production of messages related to the filing including media, financial and FAQ materials
Work collaboratively with other leaders in Department to manage overall workload and workflow. Assist in preparation of internal reports and metrics. Interact with key regulatory agencies and staff as necessary
Develops, selects and retains a multi-functional, diverse and well-trained workforce which is motivated and empowered. Models innovative approaches. Promotes employee involvement in continuous learning and enhancing job/industry knowledge and skills

132

Manager Regulatory Liaison Resume Examples & Samples

Interface with regulatory agencies (CFPB, FRB, FDIC, etc)
Provide support and guidance to the business in preparation for, during, and after examinations
Advise the CCO and business on likely reactions from bank examiners
Assist in development of responses to examiner and supervisory recommendations
Develop a tracking mechanism and ensure timely and appropriate responses to regulator requests and responses to MRAs and MRIAs

133

Regulatory Product Manager Resume Examples & Samples

Prepare and submit regulatory package/ supporting documents to ensure registrations are achieved, defended and maintained according to plan
Ensure registration plans and timelines are set through dialogue with relevant functions and communicated to relevant stakeholders in an appropriate manner and that risks in achieving registrations are communicated to and accepted by the business
Ensure registration plans are revised to reflect any changes in data requirements or the regulatory environment and the revised plans are clearly communicated to relevant stakeholders
Ensure that regulatory input is provided into development programs and reports for consistency and fitness for the purpose
Anticipate any significant safety matters impacting upon our ability to obtain registrations by ensuring appropriate safety assessments are conducted and make recommendations to mitigate the impacts
Develop and maintain high quality relationships with internal and external customers, including regulatory authorities and key influencers
Identify and advise Commercial Team and/or Business Partners of any significant matters impacting upon our ability to obtain registrations for product portfolio
Use knowledge of products and regulatory system to advise Commercial Team on competitive regulatory positioning to optimise products in the portfolio
Broad knowledge of regulatory and scientific affairs
Experience in regulatory activities
Working knowledge of a broad range of scientific disciplines (including biology, toxicology, environmental chemistry, etc.)
Good understanding of the significance of scientific data in the regulatory context
Science-based degree or at least 5 years’ experience working in a regulatory function, preferably in crop protection
A sound understanding of safety assessment in crop protection

134

Manager, Regulatory Enforcement & Compliance Resume Examples & Samples

Conduct, manage, and support compliance auditing/monitoring programs and maintain knowledge and understanding of relevant industry regulations and guidelines
Perform operational assessments of financial and clinical departments with a focus on documentation and coding, revenue capture, billing and claims, and quality reporting
Maintain daily contact with client and other members of working group to obtain information and resolve issues, attend working group meetings, and facilitate the adoption and implementation of recommended improvements
Prepare and review engagement work papers and develop written briefings and reports to present to healthcare clients and educate them on operational leading practices
Conduct a ”deep dive” into details of a business while staying focused on the big picture
Provide value-added recommendations to support the long-term growth of the department and supervise and mentor staff
A minimum of five years of experience in either Compliance or Internal Audit in a hospital, physician or healthcare consulting role; relevant experience with a Big Four accounting firm and/or experience within an Internal Audit department of a large multinational company is preferred
Working knowledge of CPT/HCPCS, ICD-9, ICD-10-CM and ICD-10-PCS coding, billing, and claims
Exceptional interpersonal skills demonstrating the ability to gain the confidence and respect of senior executives as well as strong client services orientation and accustomed to taking an active role in organizing and managing multiple engagement priorities

135

Manager, Regulatory Risk Resume Examples & Samples

Assist clients with addressing enterprise wide compliance, including compliance risk management programs, third party compliance reviews, privacy/customer information security, fair lending, the Community Reinvestment Act (CRA), the Home Mortgage Disclosure Act (HMDA), and the Unfair Deceptive Acts and Practices (UDAP)
Write and present clear and concise reports and presentations containing meaningful recommendations to clients
Contribute to industry and regulatory publications, write professional articles, and speak about current compliance issues at external seminars
Lead consumer compliance regulatory business development efforts for primary target clients
Schedule, plan, assign, and provide direction and review the work of the team members working on assigned engagements
Lead business development efforts for primary target clients
Provide a leadership role on KPMG thought leadership efforts
A minimum of five years of applicable recent consumer compliance regulatory work experience in a combination of the following: enterprise wide compliance, privacy and customer information security, fair lending, CRA, compliance risk management programs, and UDAP
Progressive experience leading teams and managing projects, and strong client services skills and accustomed to taking an active role in executing engagements
Demonstrated track record of leadership, client management, project management, and business development
Established business development and advisory experience and exceptional interpersonal skills with a demonstrated ability to gain the confidence and respect of senior executives
A minimum of eight years of advisory services or project management experience
Progressive experience leading teams and managing projects and ability to manage a multi-disciplinary team

136

Manager, Regulatory & Accreditation Resume Examples & Samples

Minimum Education
Minimum education, training and background for the successful candidate include
Bachelors preferred, with experience in regulatory requirements and accreditation standards, performance improvement as applicable in other related areas of responsibility
Requires an advanced degree in a health related field (Masters or Doctorate) within five years of relevant facility management experience
Knowledge of TJC and other regulatory standards
Knowledge of CMS CoP Conditions of Participation and other federal requirements
Knowledge of CMS CoP Conditions of Participation and other state requirements
Knowledge of principles of quality improvement
Relevant clinical experience
Strong written skills

137

Manager, Regulatory Documents Resume Examples & Samples

Accountable for: oversees activities of RDRs (Regulatory Document Reviewers) in the collection, review, and approval of site essential documents, including placement in relevant systems (e.g. Clinergize); oversees regulatory submissions to IRB for all assigned trials; identifies and communicates operational issues on assigned trials based on input from RDRs, trial team, or IRB vendor; represents regulatory document review function on assigned trial teams, including planning of regulatory document start-up and maintenance activities and operational input for regulatory documents (e.g. protocols, advertisements, etc.); monitors the progress of regulatory document collection activities for assigned trials and supports efforts to mitigate delays and issues)
Represents regulatory document function during audits and inspections
Supports leadership in qualifying vendors (e.g. IRB)
Develops and implements regulatory documents-specific and trial metrics and tools to report on, provide visibility into, and analyze performance and deliverables
Manages and guides efforts of third-party vendor(s) to address performance issue for in-sourced resources (RDRs) and ensure deliverables are of high quality within planned timelines against contracted scope of work (SoW)
Monitors RDR resource allocation and usage for assigned trials
Maintains a focused continuous improvement culture by identifying and executing strategies and priorities to enable the Regulatory Documents group to deliver value and enhance overall operational effectiveness
Actively remains current with industry standards, trends, and competitive intelligence on regulatory documents best practices
Supports close relationship with all ClinOps groups, Legal, Ethics & Compliance, CDMA, Translational Medicine, Finance, and QM to assure a closely coordinated program of activities based on common objectives and focusing on value, quality and operational efficiencies
Liases with Central IRB throughout duration of the trial
Leads and/or represent Regulatory Document processes on local/global working groups
Develops and delivers appropriate training for the Regulatory Documents group in partnership with the Training and Compliance group

138

Associate Program Manager, Regulatory Resume Examples & Samples

Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects
Stays abreast of therapeutic area product development and other related business strategies and plans
Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
Documents meetings, teleconferences and other interactions/communications with regulatory authorities
Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
Supports Regulatory Program Management Program Directors with a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation. Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and Roche standards
Supports management of relevant project budgets to ensure compliance with agreed parameters and provides routine and ad hoc budget reporting and other updates
Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Regulatory Program Management-specific systems, processes, Standard/Department Operating Procedures (SOPs/DOPs) or other relevant tools

139

Manager, Regulatory & Quality Resume Examples & Samples

Interpret and apply regulations by creating regulatory strategies for ANZ markets
Ensures quality and regulatory compliance in accordance with documented quality system procedures for all aspects of functional responsibility
Train, reinforce and coach function teams on compliance requirements, procedures and practice
Assist product quality complaints on time reported to Manufacturers, Review/collaborate on complaint investigation reports as needed
Coordinate quality and regulatory compliance activities/issues when needed
Provide assessments and recommendations on non-conformance and product quality issues for regulatory compliance. Supports continuous improvement through detailed failure analysis for non-conformances, investigates, support compliant solutions developed and effective implemented as corrective and preventive actions
Manage the process for reporting of any adverse events
Keep informed of new and revised regulations; disseminate information as directed by management
Provide regulatory guidance and/or training to external departments and marketing partners
Actively participate in USA, Regional and ANZ RA & QA teams and work groups
Assist in conducting internal/external audits, as needed
Assess manufacturing process and labeling changes for regulatory reporting impact
Advanced written and oral communication
Experience and knowledge of TGA regulations applicable to Diagnostics, X-ray equipment and surgical devices
Quality Management System (QMS) experience in the medical device field

140

Manager, Regulatory Risk & Governance Resume Examples & Samples

Implementing a corporate risk framework, which outlines our approach for managing risk
Developing policies and procedures for identifying, measuring, monitoring, managing and controlling those risks identified in the corporate risk framework
Establishing appropriate corporate risk tolerance levels
Deploying capital on an economic basis
Recommending capital allocations on an economic capital basis; and
Reporting to (i) the Finance and Risk Committee of MetLife, Inc.’s Board of Directors; (ii) the Investment Committee of MetLife, Inc.’s Board of Directors; and (iii) the financial and non-financial senior management committees on various aspects of risk
Assist in the quarterly and annual review of the financial statements and risk factors
Support ongoing Board Reporting including the Qualitative Assessment of Capital, Emerging Risks and Top Risks
Support quarterly reporting to Board and Risk Committees that include but is not limited to the Enterprise Emerging Risk Committee, NAIC ORSA Steering Committee
Support the Emerging Risk Management framework that includes coordination and perform deep-dive emerging and other risk assessments; coordinate information for the Enterprise Emerging Risk Register and Regional Emerging Risk Summary
Manage GRM’s risk awareness program including but not limited to written articles for a global audience, coordinate and write the GRM newsletter; make recommendations for the program
Ongoing project management supporting the planned separation, rebranding among others
Bachelor’s degree in risk management, finance or accounting is highly preferred; CPA, CFA, FSA is a plus
Prior experience working in the financial services industry, preferably an insurer
3+ year(s) of experience in any of the following fields: regulatory reporting, operational risk, governance
Proficiency with Excel, Word and PowerPoint

141

Senior Project Manager Regulatory Resume Examples & Samples

Defining project objectives and deliverables with stakeholders
Structuring and planning of the project
Ensure compliance with the project group wide standards as well as the internal quality standards defined in the Project Life Cycle approach

142

Manager, Regulatory Policy Resume Examples & Samples

A covering letter (maximum of 1 page)
A response to the following targeted questions (maximum of 1 page for each )
1) Please outline a recent example of where you evaluated and reported on risk and performance across a system or project. What was your approach, what did you consider to be the major considerations and issues, and why?
2) Please outline an example of where you have developed and monitored a regulatory or performance related strategy. How did you determine objectives, assess and evaluate success, monitor trends and implement required changes?

143

Manager, Regulatory Compensation Resume Examples & Samples

Interpret, communicate, review and track exam requests to ensure team members deliver requested items timely, accurately and completely
Draft and update policies, procedures, process maps, etc
Coordinate department internal review responses and any applicable action plans

144

VP-program Manager Regulatory Reform Resume Examples & Samples

Accountable for mandate inventory completeness, accuracy, transparency and relevance for both proprietary and covered funds mandates
Responsible for RMH hedge effectiveness testing and controls
Primary liaison with Risk, Desk, Legal and Compliance for mandate related activities
Review, develop and analyze business specific testing and controls pertaining to the Volcker rule
Market Risk or other risk management experience is highly desirable
Strong project management skills; ability to gain consensus among staff and drive initiatives to completion effectively

145

Manager, Regulatory Policy & Analysis Resume Examples & Samples

Advanced degree in engineering, environmental policy, economics or environmental science
At least 5 years of experience in conceiving, leading and/or executing economic, policy and regulatory analyses related to climate change, clean air policy, or energy policy
Professional experience directing or managing technical analyses by outside consultants
Familiarity with energy and economic analytical tools including power sector dispatch models, and major private and public databases of energy and environmental information
Familiarity with major federal Clean Air Act programs as well as the federal and state administrative policy making process
Proven ability to conduct economic analysis related to climate policy; evaluating and quantifying economic impacts; analyzing data, applying models, designing scenarios and producing research reports and briefings
Demonstrated ability to work independently and initiate high-impact projects while forging strong collaborations with multidisciplinary teams
Demonstrated ability to oversee complex projects and solve challenging problems
Experience providing litigation support on complex, fast-paced technical questions
Demonstrated ability to effectively communicate technical and policy findings to colleagues, policymakers, other stakeholders and allies, journalists and the general public

146

Regulatory CMC Associate Manager Resume Examples & Samples

Timeliness of deliverables: No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate documentation on matters within CMC control
No last minute source document issues identified that could have been prevented by early review of source documents
Ensure that CMC regulatory documentation follows Novartis guidelines and meets regulatory guidelines, as appropriate (e.g. measured by approval of CMC documentation and no non-approvals due to CMC issues under our control)
Positive customer feedback
Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable
Effective planning, organizational and interpersonal skills
Reasonable approach to risk assessment

147

Manager Regulatory & Risk Analytics Wholesale Credit & Market Risk Resume Examples & Samples

The volume of rules, policies, procedures and reports to be maintain and update on a regular basis is considerable large and complex
The level of interaction with internal and external stakeholders is high and the reports produced are taylored for senior executives and regulators
Bachelor’s degree in business, related field or equivalent experience
Minimum of five years proven, progressive and broad-based banking experience, including commercial lending, loan structuring, credit administration, regulatory compliance and related systems experience, or equivalent
Strong project management, organizational, communications and interpersonal skills
Supervisory experience and asset
Proficiency with personal computers, systems and software packages

148

Assistant Manager, Regulatory Science Resume Examples & Samples

Provides regulatory guidance and expertise for development of labeling materials for U.S. marketed products
Prepares technical label copy (TLC) for MJ products; reviews and approves artwork and proofs for accuracy; and reviews and approves promotional materials in accordance with the LEX (labeling excellence) process and procedures
Drives regulatory processes to ensure timely filing, registration (including exported products), approval, and/or maintenance of product registration in accordance with US regulatory requirements and with business objectives
Supports export market requests with product information and documentation
Stays abreast of, interprets, and communicates existing and/or proposed government regulations, registration requirements, and labeling changes to Operations, Business, and R&D disciplines and applies these changes as necessary to facilitate MJN's business plans and long-term goals
Serves as a primary representative of/spokesperson for Regulatory Science on project teams to ensure regulatory compliance
Establishes and maintains communication channels and constructive rapport with key partners in R&D and Supply Chain to streamline and maximize information and documentation flow
Understands and communicates US FDA regulations and procedures for MJ products, especially Infant Formula, and how regulations may impact work assignments
Authors or updates Regulatory Science standard operating procedures and work instructions
Manages regulatory-related projects to assure MJ products are in compliance with new/revised regulations
Maintains accurate databases for regulatory submissions, references, internal documents, export market registration, and web-based applications and shared drives for document sharing
Supports industry association activities related to US-manufactured products
Demonstrated ability in preparing and maintaining dossiers such as registration submissions for regulated products
Demonstrated knowledge of US labeling regulations
Demonstrated ability to work with a range of technically and culturally diverse people, collaborate in team projects, and deliver value-added business results that meet high quality requirements within tight deadlines
Experience in working with information databases
Experience in dealing with issues pertaining to the launch and support of new products
Combination of training in scientific disciplines, such as Nutrition, Food Science, Chemistry, Pharmacy or Biochemistry and experience in food regulation-related field preferred
Basic understanding of the regulatory and registration requirements for U.S.-manufactured products
Familiarity of the necessary requirements and time constraints for registration, labeling and advertising of MJ products
Working knowledge of MJN computer systems and databases
Basic understanding of Spanish language

149

Regulatory Training Manager Resume Examples & Samples

Work with Regulatory Control and Treasury Capital teams to identify and prioritize the on-going regulatory training requirements
Partner with internal stakeholders across Finance and Subject Matter Experts (SMEs) to oversee creation of new course materials
Refresh existing training materials for up-to-date content based on new regulations, regulatory guidance or best practice standards
Work with consulting firm to create sustainable online content based on the Firm's needs and requirements
Oversee timelines and logistics to deliver the training to tight deadlines
Monitor and enforce mandatory completion requirements
Gather user feedback to assess the quality of course topics and training materials
BS degree in Accounting, Finance or related field
Proven organizational skills and an ability to prioritize tasks to ensure key deadlines are met
Strong team player who can build relationships across departments
Ability to manage multiple deliverables while paying strong attention to detail
Ability to translate complex subject material and concepts into broad based and also targeted course materials
5-7 years of relevant experience; regulatory reporting or training experience a plus
Understanding of industry best practices and standards
Demonstrated proficiency in MS Office applications

150

Project Manager / Regulatory Audit Analyst Resume Examples & Samples

Evaluate incoming request from regulatory/auditing agency and determine deliverables, responsible parties, timeline, and potential risks
Evaluate policies and procedures to ensure that they are implemented and well documented
Provide significant assistance in completing internal reviews, make recommendations and monitor implementation of changes as necessary
Identify and track key project milestones to ensure compliance with established delivery date
Coordinate with internal stakeholders to resolve outstanding requests/inquiries
Review key issues with business leaders to determine root cause and implement a resolution
Communicate with external stakeholders such as outside counsel as necessary
Provide information and status reports to upper management
Manage the approval process with senior management and counsel if necessary
Coordinate vendor review and on-site visits
Assist with the development of requirements for a new technology offering that will automate collection process
Role requires difficult communication to be handled professionally with tact, discretion, and clarity
Highly developed analytical and interpersonal (written and verbal) skills
Strong analytical and problem solving skills with the ability to effectively resolve moderately complex situations
Detail oriented with strong project management, organization and planning skills
5 plus years of mortgage experience, including strong knowledge of the fair lending rules
Understanding of regulatory topics, concepts, practices and procedures related to the life of a loan (origination, servicing, loss mitigation and default/foreclosure)
Expert skills in Microsoft Office Suite
Must be self-motivated, and have the ability to work and multi-task in a face paced environment
Bachelor's degree in Business, Economics or related field or equivalent work experience
Must be able to manage expectation and manage others in senior leadership roles

151

Manager, Regulatory Quality Review Resume Examples & Samples

You are a multifaceted leader
You love understanding the big picture (and why the details are so important)
You have the ability to manage competing priorities with ease
You treat others with dignity and respect while driving business deliverables
You are a critical thinker
You’ve got exceptional research skills
You believe in empowering your team
Compliance is your middle name
You go above and beyond in your role because you want to, not because you have to
3 years in managing exempt and non-exempt team members and projects
3 years of flood experiences (Biggert Waters) and knowledge
3 years of operational compliance or audit experience
3 years of insurance, mortgage or financial services experience or Masters in related field
3 years knowledge of internal or external auditing duties or operations to be audited, knowledge of data analysis and improvement tools
3 years of regulatory compliance governing the mortgage, insurance and/or financial services
Bachelor’s degree, preferably in Business Administration, Finance or related field or equivalent work experience required
Process improvement training/experience
Certified Compliance Ethics Professional (CCEP)
Certified Regulatory Compliance Manager (CRCM)
Internal auditor certification (IIA, CIA)
Excellent oral, written and presentation skills
Experience in managing virtual teams
Demonstrated problem resolution skills
Ability to use MS Excel to enter and correct data, modify a workbook, format a worksheet, format charts, filter date and create basic formulas for data trending
Ability to use MS Word for basic formatting, editing and printing function and understands the document page set up
Ability to use MS Office including Access, PowerPoint, Project and Visio
Ability to use Tableau reporting and dashboards
Ability to use Minitab
Able to implement a review, collect and verify review evidence, assist with preparation of preliminary/final reports, write work papers to summaries findings and open CARs/CAPs for remediation purposes

152

Project Manager Regulatory Resume Examples & Samples

Be responsible for projects assigned to him/her, on enhancements and new business projects
Engage and follow up with IT teams in Paris and Bangalore
Identify and implement initiatives bringing value and efficiency to the end users
Participate, follow-up Local, Regional or Global projects for Asian users
Working with vendor teams is needed
Promote and ensure the use of standard project follow-up tools (Pyramid, Prime)
Proven capability of following up a project’s planning and budget. (PMI-PMP certified)
Experience in Agile project management (PMI-ACP certified)
Knowledge in Banking and deals processing area
Regulatory topics: EMIR, DFA, FATCA, MIFID
Ability to steer distant development teams
Ability to work with remote users / teams and vendors
Excellent English communication skills both spoken and written
Autonomy
7 years of relevant experience, including 5 as business analyst and project manager

153

Assistant Manager, Regulatory Resume Examples & Samples

Support on-going activities related to Automated Exchange of Information (AEOI) obligations
Manage daily/monthly/quarterly AEOI activities including IRS/ local registrations, periodic reconciliations, control certifications, provision of information to counterparties etc
Assist in quality control of AEOI related regulatory filings
Support jurisdictional FATCA/ CRS Responsible Officers to efficiently fulfil their AEOI related responsibilities and obligations
Coordinate with internal/ external stakeholders to resolve AEOI related issues/ queries
Monitor AEOI related regulatory developments/ timelines and ascertain there impact on Invesco
Support AEOI related change management processes and activities
Manage and support Legal Entity Identifiers (LEIs) processes
Manage LEI processes related to acquisition, renewal, and change management of Invesco’s Legal Entity Identifiers
Coordinate with stakeholders across Invesco for LEI related processes and information
Monitor LEI process related regulatory developments and assist in analyzing their impact on Invesco
Maintain highest degree of data quality and process integrity
Work closely with various stakeholders to identify opportunities for automation / streamline in-scope processes. Post that define/ document solution, gather requirements, plan and implement
Build strong relationships with internal and external stakeholders
Assist in other regulatory driven initiatives/ projects including liaising with Legal and Compliance colleagues to determine regulatory impact on Investment Services
Experience within financial services (investment management/banking/insurance), is desirable
7 to 10 years of experience working in financial services firms
Understanding or prior experience of working on FATCA/ CRS related initiatives is required
Compliance/Operational Risk /Centralized Compliance Operations experience is a plus
Good knowledge of regulatory requirements applicable to Investment Management firms
Experience with drafting, implementing and monitoring procedures and controls
Strong Microsoft office experience required
Deep understanding and experience of regulatory change programs, is desirable
Strong analytical skills and writing skills, to include solid experience in writing business and functional specifications
Ability to build relationships by communicating, influencing and negotiating effectively with senior stakeholders, project team and technical experts across a global scenario
Must be a detail-oriented, self-starter with strong organizational skills
Superior interpersonal skills necessary to effectively interact and communicate with other team members and senior stakeholders
The ability to multi-task on various projects and prioritize amidst competing demands
Good verbal and written communication skills combined with ability to listen effectively
Good troubleshooting and problem solving skills
Action-oriented. Able to establish priorities, meet deadlines, and concentrate on detailed information in a fast-paced demanding work environment
Strong work ethic. Knowledge of Investment Management industry, data and processes is a plus

154

Manager, Regulatory Medical Device Resume Examples & Samples

A minimum of five years of project management experience within a regulatory medical device environment including but not limited to European medical devices; a minimum of three years of working in regulatory or QA of medical devices
Exposure to post market surveillance, product labeling, and regulatory information management
Travel may be up to 80-100%
Applicants must be currently authorized to work in the United States without the need for visa sponsorship now or in the future

155

Manager, Regulatory Labeling Operations Resume Examples & Samples

Provide a support function to the product leads for US and EU artwork
Subject Matter Expert (SME) for all matters relating to product labeling artwork, including involvement in continuous improvement activities
Work with the Supply Chain team to help manage the packaging update process following approval, including progression of artwork via Shire’s Artwork Management system (SAMs)
Review new packaging and complete all steps required to implement the packaging. In the EU, this includes obtaining translations, linguistic review including liaison with Regulatory Agencies, progression of artwork via SAMs
Regulatory assessment of changes impacting artwork
Assist GRA Strategy Product Leads with change controls
Management of external consultants (as required)
Maintain compliance of approved texts and approved packaging
70% of time
Liaise with Regulatory Agencies and GRA Strategy Product Leads/Specialists on product updates impacting labeling
Attend meetings with supply chain logistics
Attend meetings for new product launches (as required by GRA Strategy Product Leads/Specialists)
10% of time
Author and review Shire’s standard operating procedures and associated documents relating to artwork/regulatory involvement with Supply Chain
Dispatch revised product labeling to the different departments inside and outside of Regulatory (as appropriate with local requirements.)
Train and advise functions on labeling requirements, including updating relevant functions on changes to labeling legislation
Vast experience in the pharmaceutical industry, specifically in Supply Chain, Regulatory or Packaging Design
Expertise in US and EU packaging regulations preferred
Awareness of the print industry and manufacturing techniques and how they impact packaging design
Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation
US and EU artwork experience is strongly desired
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels internally and externally, with strong negotiation skills
Excellent analytical and communication skills both verbal and written
A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach
Ability to manage complex projects and timelines in a matrix team environment
Strong attention to detail and accuracy is a must
Ability to effectively present information to Shire functions (as required)
Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness
Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict
Ability to articulate a clear vision and help others understand their relationship between their roles, the roles of others and the overall goals of Shire, and demonstrate flexibility, energy and resilience throughout change efforts
Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to work in diverse teams to optimize decision-making
Demonstrated ability to provide coaching and feedback to foster professional development while also supporting business goals, if applicable
Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines. Must have experience with industrial interpretation with respect to regulatory expectations
Applicable knowledge of the drug development process
Proficient in business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook
Strong interpersonal, managerial and organizational skills

156

Project Manager, Regulatory Resume Examples & Samples

Manage Regulatory Sub-team operations, including facilitation of Subteam and Strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required)
Create and maintain Regulatory timelines and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies; create and maintain reporting dashboards for teams and management
Track submission preparation progress, including but not limited to post-marketing and annual reporting commitments, to ensure timely filing to health authorities
Document project milestones/deliverables and report progress against team, department, and corporate goals
Facilitate short and long-term planning activities
Analyze internal Regulatory Affairs and Project Management processes, identify opportunities for improvement
At least 5 years’ experience in a project management or scheduling environment; a minimum of two years’ experience managing teams and team operations
Pharma/biotech or related industry experience required
Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others
Exposure to electronic document management system(s) (EDMS) helpful
Experience with MS Project 2010, or similar scheduling software, required or proven skill at adapting to new software/technology. MS Project Server experience helpful
Knowledge of Regulatory Affairs submissions and nomenclature desirable

157

Manager, Regulatory Harmonization Resume Examples & Samples

Analyze, provide advice, and help develop strategies on proposed global food standards and potential trade issues relevant to foods and beverages (e.g., Codex, WHO, FAO, WTO)
Prepare and advocate company positions on global food standards to internal and external stakeholders
Identify opportunities for regulatory alignment in collaboration with the Scientific & Regulatory Affairs network and manage such projects
Guide and assist in preparing regulatory submissions on beverage ingredients to global organizations and other regulatory authorities
Manage the distribution of information on global standards, positions, and other regulatory information to internal clients as needed
Regulatory affairs: Experience in beverage or food industry in scientific and regulatory affairs or relevant related field in food industry, government or related industry in similar roles managing regulatory issues impacting products, ingredients, and labeling
International organizations:Experience in international food standard setting processes and reviewing and analyzing proposed standards
Advocacy:Understanding of the key issues and the relevant regulatory and scientific proof points to support regulatory advocacy by developing positions to support innovation of ingredients, products, or labeling
Ingredients:Understanding the technological need for food additives and typical contaminants found in foods and their regulatory principles defining the permissibility and limitations of use
Trade associations: Understanding of key trade associations and global regulatory policy landscape affecting food and beverage industry
Ingredient, Product and Category Knowledge: Knowledge of ingredients, product categories/formulas and materials used in production of concentrates and beverages
Global Regulatory Landscape: Knowledge of the political and regulatory landscape (e.g., laws, regulations, issues) affecting beverages in the Business Unit; the ability to manage complex regulatory issues to protect our products, ingredients, packages, or claims
Global and Supernational Authorities: Understanding how national and supranational authorities (e.g., US IOM, EU, WHO, JECFA, Codex Alimentarius) influence the regulatory environment
Experience on global food standards: Knowledge on key global food standards (e.g., Codex) and experience in the standard setting processes ability for critically reviewing proposed global standards and writing comments in response
Position Development: Ensuring that our business is not unduly restricted by onerous policies or regulations and enabling business growth. This requires an understanding of the key issues and the relevant, credible science; the ability to assess risk; skills in strategic thinking and planning; the ability to build and articulate complex scientific arguments in a clear and compelling way; and the ability to partner with, collaborate with, and/or influence key internal and external stakeholders
Collaboration and Influencing: Ability to partner with stakeholders (internal or external) to constructively shape opinions and further key objectives

158

Senior Project Manager Regulatory Management Credit Suisse Trust Group Resume Examples & Samples

Run day-to-day project work and reporting (cost control, resource allocation, risk mitigation etc.) by using your project management expertise
You will be leading the respective project partners through the entire regulatory chain – impact assessment, analysis & design, implementation and Business as Usual handover (BAU)
Specify and ensure adherence to defined task lists and implementation plans by timely raising project and delivery risks
Define and act upon excellent documentation standards to ensure traceability and audit-ability
You will lead and prepare Steering Committees and other updates to the Senior Management, giving you the chance to closely work with senior management
A University degree, ideally improved with further relevant education
You bring at least 5 years of Banking or Insurance experience supplemented with strong Project Management skills complemented with experience in Legal, Compliance or Audit in a global organization
You can apply your sound knowledge and familiarity with Trust business and related processes and duties in our energizing environment
You have demonstrated your leadership skills with sizeable strategy projects and established a track record in pursuing complex issues and executing initiatives in the context of a large organization
Your confirmed analytical and conceptual skills help us to ensure precise documentations
Structured and result-driven way of working and the ability to get things done in an operating environment
As a team-player you will supply your distinct social, analytical and problem solving skills to our team and you are comfortable to address open questions with enthusiasm
Your strong and confident communication style enables you to support us with high level presentations, tailored to the various recipients
Fluency in German and English (oral and written) is a requirement

159

Manager, Regulatory Practice & Reform Resume Examples & Samples

Leading the development and implementation of regulatory reform and operational policy to ensure that the EPA remains a responsive and flexible regulator that adheres to established regulatory best practice
Managing projects and programs that continually improve the regulatory credibility and effectiveness of the EPA with innovative approaches to protect the environment
Managing a team of who are passionate about protecting the environment, and partnering with communities, government and business to reduce environmental impacts

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