Regulatory Lead Resume Samples

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M Grimes

Mellie

Grimes

555 Nayeli Divide

Dallas

+1 (555) 581 5334

555 Nayeli Divide

Dallas

Phone

p +1 (555) 581 5334

Experience Experience

Dallas, TX

Audit & Regulatory Lead

Dallas, TX

Jacobi-Terry

Dallas, TX

Audit & Regulatory Lead

Provide comprehensive and timely support to all internal/external identified Audit & Regulatory issues and reporting
Network Architecture
Problem/Incident/Change Management
Interfaces with Business Continuity Management in relation to audit and regulatory issues, findings or queries
Direct responsibility for all regulatory and Requests for Information (RFI) originating in the Americas
Establish and maintain globally consistent processes for all GSO Audit and Regulatory activities and engagements, in accordance with firmwide standards and GTI Risk & Controls guidelines
Lead GSO efforts in preparation, engagement and remediation of all GSO-targeted and cross-impacted Audit and regulatory activities, including internal audits, external audits (e.g. Price-Waterhouse, Ernst & Young), regulatory and external audit testing activities (i.e. SOX, SSAe16, MAS, etc.)

Dallas, TX

Lead for Regulatory Program

Dallas, TX

Rohan LLC

Dallas, TX

Lead for Regulatory Program

Deliver the e-Risk feeds for derivatives business line scheduled for Calendar Year 2016
Design and Deliver the Report Matrix and integrate it with Batch Monitor which will provide daily status of all the reports and their progress to RTB in Batch Monitor for them to take corrective action
Support for strategic platform like Cash Architecture, STAR, etc., and making sure the Risk Regulatory Reports are not impacted
Support any adhoc/legal inquiry from internal/external regulators/Traders globally
Convincing and Assertiveness
Constant interaction with Senior members from Equities Derivative Risk & Regulatory Users related to RAMP/Octon or any new flow onBoarding to data warehouse
Ensure that the release cycle of Dev to SIT/UAT to Prod is followed for all report releases

present

Chicago, IL

Regulatory Transaction Reporting Quality Assurance Team Lead

Chicago, IL

Rogahn, Green and Lynch

present

Chicago, IL

Regulatory Transaction Reporting Quality Assurance Team Lead

present

Responsible for team and people management in the QA team. Performance manage and provide coaching and guidance to team members
Quick learner, with a mature attitude to responsibility and confident working as a team member or under own initiative
Engineering and building out the QA processes for APAC jurisdictions and/or other regulatory reporting
Design and implementation of automated reconciliations to test completeness across high volume asset classes
Facing off to Group Internal Audit and External Audit in their Transaction Reporting reviews
Coordinate and plan to incorporate regulatory changes, process and system changes and process excellence
Interpreting and reporting findings in a structured and objective manner to the Regional Transaction Reporting Operating Committee. Tracking patterns and anomalies in their findings

Education Education

Bachelor’s Degree in Pharmacy

University of Memphis

Bachelor’s Degree in Pharmacy

Skills Skills

Sybase knowledge is highly desirable
Strong relationship-building and influencing skills with the ability to be a team player operating with tact and diplomacy
Ability to work within tight deadlines and a dynamic environment
Knowledge or familiarity with Morgan Stanley technology environments or business applications
The ability to remain calm and cool under unexpected circumstances and time critical pressure
Comparable related experience responding to technology audit and regulatory requests would also be considered
Experience working in virtual teams across geographic boundaries
Understanding of industry best practices for Technology DR planning and BCP recovery experience
5+ years experience leading and contributing to Technology project management
DR, BCP, PMP and ITIL certifications are appreciated

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Audit & Regulatory Lead Resume Examples & Samples

Coordinate DR response to the annual Internal Audit, and other audits, and ensure any audit findings are addressed appropriately
Direct responsibility for all regulatory and Requests for Information (RFI) originating in the Americas
Supporting responsibility for regulatory and RFI requests for the EMEA and Asia regions
Globally ensures regulatory requests, client and other RFIs regarding Disaster Recovery are tracked and responded to in a timely fashion
Closely engages with TIR on regulatory requests, ensuring responses are in line with past requests or are updated as needed to reflect changes in the technology environment
Interfaces with Business Continuity Management in relation to audit and regulatory issues, findings or queries
Engages Subject Matter Experts in technology areas as appropriate to respond to RFIs and regulatory requests
Attends Industry Regulatory events as a representative of Morgan Stanley
5-10 years experience in either a Disaster Recovery/Business Continuity role or as a Technology Risk Officer or Auditor
Comparable related experience responding to technology audit and regulatory requests would also be considered
5+ years experience leading and contributing to Technology project management
Understanding of industry best practices for Technology DR planning and BCP recovery experience
Excellent Communication skills (verbal and written) with the ability to convey complex technical strategies and plans to a wide audience from technician to senior business and IT management
Strong relationship-building and influencing skills with the ability to be a team player operating with tact and diplomacy
The ability to remain calm and cool under unexpected circumstances and time critical pressure
Minimum 3+ years of commercial java experience
Need to have worked on distributed Java applications, in a service based architecture,
Need to demonstrate in-depth understanding of OO principles, design patterns and threading techniques
ANSI SQL knowledge is required
Ability to work within tight deadlines and a dynamic environment
Sybase knowledge is highly desirable
DR, BCP, PMP and ITIL certifications are appreciated
Experience working in virtual teams across geographic boundaries
Familiarity with Microsoft Office tools (Word, Excel, PowerPoint, SharePoint, etc.)
Knowledge or familiarity with Morgan Stanley technology environments or business applications

Regulatory Engagement Applications Developer Lead Resume Examples & Samples

Participate in project planning sessions with project managers, business analysts and team members to analyze business requirements and discuss the technical design and solution
Come up to speed with the firm software development policies, standard and guidelines; personally follow these standards and ensure that these are followed for the project
Develop and unit test your work following the coding standards, guidelines and patterns; help team members with the same
Document your changes and work with QA and business analyst to test and ensure solution aligns with the requirements
Oversee the QA and BA teams
12+ years hands-on experience working with a mix of enterprise development technologies including Java and J2EE and strong applicability of Object-Oriented techniques and principles
Minimum 5+ years working as a development lead, mentoring junior developers and with experience in all phases of software development including design, configuration, testing, debugging, implementation, and support of large-scale, business centric and process based applications in large-scale distributed technology projects in a Java / J2EE environment
Excellent written and oral communication skills and demonstrated ability to interact with all technical and non technical members of the organization
Solid Java 7 skills with clear understating in data structures and multithreading
Application development on a RDBMS like Oracle. Create efficient SQL queries
Application server (Tomcat, WebSphere, etc)
Web MVC frameworks like Spring MVC, Struts2 etc
JavaScript, JQuery or any other client side frameworks like AngularJS, ExtJS

Data Governance & Regulatory Program Lead Resume Examples & Samples

Develops and maintains working relationships with business leaders/strategy owners/enterprise partners including global Data Governance
Applies expert knowledge and experience with business manager tools, deliverables, and project management disciplines
Manages multiple concurrent projects and owns delivery of successful business outcomes
Conducts profiling of data sets
Conducts data quality assessments and lead conversations to develop data quality rules
Discover, document, and analyze data collection and data transformation processes to determine the cause of systematic errors or data quality improvement opportunities
Upon finding root causes of errors, proposes solution or options for correction and prevention
Be point of contact for all IMR (Issue Management Resolution) issues pertaining to the Retail Bank
Work with the business to create, document, and move CAP’s to resolution
Create project requests and lead regular project meeting calls; especially as it relates to CitiKYC
Bachelor's degree in a financial services related field required or equivalent work experience
5-8+ years relevant experience
Experience in consumer/retail banking or financial services preferred
Understanding of data quality management principles
Solid working knowledge of core business functions such as quality management, data management, business intelligence, and information technology
Experience in program and project management; Experience in relating regulatory, compliance and quality initiatives
Strong written, verbal, and interpersonal communication skills
Ability to think strategically, creatively problem solve, and the ability to engage resources outside of their direct control to achieve objectives
Cooperative problem solving mindset; Able to work well across multiple functional areas
Solid understanding of business strategy and IT landscape
Proven ability to communicate business rationale to internal and external counterparts
Knowledge of data, reporting and analytic functions within a financial services organization
Familiarity with SQL and/or SAS a plus
Demonstrated ability to deal with ambiguity and to interface with internal and external resources to define requirements

International Regulatory CMC Liaison Lead Resume Examples & Samples

Participate in applicable CMC/QA team meetings to provide International regulatory guidance and perspective
Provide input, evaluation and assessment in a timely manner from an International perspective of Manufacturing and QA deviations and change controls as needed including preparation of summaries and assessment reports. Support, guide and coordinate the implementation of agreed actions to be executed by local RA personnel
Provide guidance/advice on international regulatory (CMC) environment and provide assessment of the impact of new and changing regulations/requirements as applicable
Represent the International Region in GRA Teams as needed and provide international regulatory guidance to CMC, preclinical, clinical for development programs and marketed products
Represent the International Region at the Global level in relevant forums and projects (e.g. SOP and training development, commitments database, process improvement initiatives, etc)
Support business case development activities for new markets by working with cross-functional teams based in US (Global logistics, Tech Ops, QA, QC and others) and international regulatory leads
Support RA Director International and assist the International RA team on specific and agreed projects
Science degree required, higher degree preferred
7-10 years regulatory experience in drug development and/or international regulatory affairs
Excellent working knowledge of pharmaceutical regulations as they relate to the region of responsibility

Regulatory Tech Lead / Project Lead Resume Examples & Samples

Extensive experience working on large, global programmes, including years as project lead
Experience in the Financial Services industry
Experience working on Regulatory Reporting would be advantageous
Expert working with a development team through story planning, capacity planning, estimation and prioritisation
Expert in core Java concepts, data structures, and algorithms
Excellent understanding on the programming principles, design patterns and OO best practices
In-depth knowledge on Spring, Hibernate and messaging implementations using JMS
Strong understanding of concepts and technologies related to data and database management: relational databases/Oracle, 3NF and dimensional data modeling, data warehousing
Understanding of concepts and technologies related to big data / NoSQL (Hadoop, Cloudera, MongoDb) would be advantageous
Good understanding of concepts related to user interface design and RIA web technologies
Strong analytical, problem solving and organizational skills
Excellent collaborations skills and ability to work in a global team
Have a keen eye for process improvement and cost control

Senior Technical Lead-regulatory & Tax Resume Examples & Samples

Champions standards and takes corrective action when they are being breached
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

Lead Regulatory Coordination Resume Examples & Samples

Provide support and ensure Americas specific requirements are included in key regulatory programs such as Service Co / Legal Entity Program and Third Party Risk Management incl. implementation of requirements coming out of these programs
Ensure appropriate engagement of key stakeholders in the Americas region including set up of appropriate briefings on progress of the key regulatory programs and participation in local working groups
Responsible to ensure overall Third Party Risk Management Program and related policy / processes are compliant to Americas specific regulations and work with the other regional regulatory coordinators to update respective global policies as needed
Single Point of contact for Americas related regulatory, compliance and control inquiries on third party vendors and contracts to ensure consistent messaging
Ensure SVM is aware and adheres to local laws and regulations and communicate relevant changes and enforce compliance as needed
LI-KJ1*

Lead Regulatory Coordination Resume Examples & Samples

Provide support and ensure APAC specific requirements are included in key regulatory programs such as Service Co / Legal Entity Program and Third Party Risk Management incl. implementation of requirements coming out of these programs
Ensure appropriate engagement of key stakeholders in the APAC region including set up of appropriate briefings on progress of the key regulatory programs and participation in local working groups
Responsible to ensure overall Third Party Risk Management Program and related policy / processes are compliant to APAC specific regulations and work with the other regional regulatory coordinators to update respective global policies as needed
Single Point of contact for APAC related regulatory, audit, compliance and control inquiries on third party vendors and contracts to ensure consistent messaging

Global Cyber Regulatory & Audit Lead Resume Examples & Samples

Manage deliverables pertaining to Regulatory & Audit engagements, including responding to inquiries, managing examinations, and providing substantiation material
Establish and drive a consistent review and communications process with regulators, collaborating with the firm's global Compliance organization
Ability to develop and maintain strong partnerships with key stakeholders, and to work across LOBs and regions, balancing the needs of multiple organizations
Strong PC skills including thorough knowledge of Microsoft Office Suite

Regulatory Process & Standards Lead Resume Examples & Samples

70% Drives the development and update of GRA processes and standards
Responsible to collaborate with GRA service leads, GRA professionals and Shire functions to develop, maintain, update and implement global (or regional) operational processes, standards and guidance documents for all GRA services as needed
Work collaboratively with GRA leaders and cross-functional R&D representatives to ensure the global implementation of harmonized SOPs, processes and standards
Alerts GRA Process Standards and Training Director of significant deficiencies in process and procedural standards and recommends optimization and corrective action plans
Identifies potential areas of process vulnerability and risk; recommends corrective action plans for resolution
Responsible for the optimization of processes to support GRA’s strategies globally and ensure that the company’s regulatory programs are optimally designed and executed
Accountable, directly or through matrix structure for GRA process optimization, including but not limited to
Mentoring GRA employees/consultants
Participating in interviewing, hiring and training employees/consultants
Planning, assigning and directing work in a matrix environment
Developing risk management plans and overseeing implementation
8 - 10 years of pharmaceutical experience in an R&D environment
Generally has at least 3 years of project management experience in a matrix environment
Experience in drug development strongly preferred
Process consulting and/or documentation authoring experience strongly preferred

Risk Regulatory Project Lead Resume Examples & Samples

Manage a dedicated team
Quantitative support to regional modelling and analytical efforts
Support regional ICAAP and other regulatory efforts. This will likely include coordination of the projects (minutes, status monitoring, etc), writing and modelling, as well as understanding the local regulatory requirements and finding pragmatic solutions to meet these requirements
This position includes significant use of advanced excel techniques and potentially statistical software (e.g. R), as well as ability to direct, organize, and control detailed projects
Experience in regulatory stress testing is desirable but not a must
Practical data modelling, validation, pricing or analytical experience is of if interest
Strong quantitative skills, particularly around statistics and and strong attention to detail
Exceptional writing and spreadsheet skills, with ability to synthesize complex concepts, translate into "user-friendly" language, and effectively present in text or slide format
Able to manage and prioritize a small team juggling multiple projects with tight deadlines
Excellent influencing, facilitation, and partnering skills, with ability to build a strong internal network across functions and expand within Risk
Strong attention to detail, willingness to "roll up sleeves"; tireless work ethic

Regulatory Transaction Reporting Quality Assurance Team Lead Resume Examples & Samples

Engineering and building out the QA processes for APAC jurisdictions and/or other regulatory reporting
Internal audit of pre-defined controls that measure adherence to the guidance set by APAC regulators
Ensure proper maintenance, documentation of control inventory; incorporating and executing new controls in a standard way that allows them to be understood by a third party
Design and implementation of automated reconciliations to test completeness across high volume asset classes
Facing off to Group Internal Audit and External Audit in their Transaction Reporting reviews
Assisting to prepare the material for the various Transaction Reporting Governance forums from risk meetings, regular Steering Committees through to Board meetings
Responsible for team and people management in the QA team. Performance manage and provide coaching and guidance to team members

Industry & Regulatory Engagement Lead & Change Management Lead Resume Examples & Samples

The individual will be responsible for running the entire book of work in respect of Change management
In addition the individual will be responsible for setting out in partnership with Technology the future state architecture of the Emea Payments and Receivables Business
The individual will also be responsible for the management of all costs associated with Technology and will be required to identify and implement cost saves on an ongoing basis
The individual will be responsible for managing the Risk and Control Agenda for Payments and Receivables and through that engaging with BRCC and other relevant forums to ensure appropriate representation for the Payments and Receivables business
The individual will be responsible for defining the Payments and Receivables strategy in respect of regulatory change
The individual will be responsible for working with the cluster leads and the Global Market Strategy lead to implement a structured engagement with Central Banks and regulators across the region to advice on best practices for change
The indiviudal will lead the readiness for regulatory reviews and exams with OCC, PRA, PSR, FCAetc
The individual will be responsible for the proactive management of the ongoing assessment of the strength of our sanctions screening infrastructure
The individual will ensure that all new Product development involving technology development follows the defined PLF framework
This is a senior role with excellent development opportunities
Will gain knowledge and insight into setting of business strategy
Will interact directly with regulators and central banks across the region
Will develop core Product Management skills
Experienced individual with strong understanding of and preferably experience in managing change programs
Excellent knowledge of core attributes of Payments and Receivables functional structures required
Ability to lead complex change programs required
Strong presentational skills required
Experience of managing PandL preferred
Strong understanding of Payments Architecture, Payment Systems and Payment Messages is a key requirement
Extensive years of experience either in Product Management or in Change Management and atleast 2 of those operating in a senior position
Desirable – Degree or Post graduate degree in Business or equivalent

BA Lead-regulatory Programs Resume Examples & Samples

10-15 years relevant work experience in Financial Institutions especially in Regulatory projects
In-depth understanding of business processes, financial products and regulatory requirements
Excellent analytical skills, business analysis expertise and hand on experience in writing functional specification/solution document for large projects
Has previously lead / managed sizable team of BAs in cross-border system implementations
Extensive system / project implementation experience. Appreciation of system and data architecture for core financial systems
Excellent strategic analysis, problem solving, issue resolution and decision making skills

Latam Corporate Policies & Regulatory Tracking Program Lead Resume Examples & Samples

Represent LatAm Region and its interests in global policy committees
Advisory Compliance lead on all Citi global and regional policies
Approve the issuance of new policies, procedures and guidelines
Represent LatAm in all facets of policy drafting and implementation, ensuring that global strategies consider local legal and procedures of the region, this will require a high level of interaction with the CCOs, General Counsels and CCCOs in the Region, solicit engagement to identify Compliance risks
Draft Regional level policies, socialize them within the region and globally where needed
Act diligently and proactively in the maintenance and communication of the entire compendium of compliance policies applicable to the region
Maintain the LatAm Region Compliance website, coordinating content across Compliance teams
Lead the LatAm Region Policy Approval Committee, chaired by the LatAm Compliance Region Head and attended by the LatAm Region CAO, General Counsel of LatAm and Senior LatAm Business Heads, or their delegates
Work with internal / external stakeholders and proactively represent LatAm Region Compliance
Develop policies implementing regulations or other regulatory projects within the region
Early identification and assessment of compliance and regulatory risk; define controls for mitigation
Strengthen Citi's regulatory risk profile by: deepening the firm’s intelligence regarding areas of increased regulatory focus; strengthening practices to identify and resolve – across the region - control weaknesses identified in the course of regulatory exams
Drive consistent execution of exam related responsibilities
Enrich the firm’s ability to track, report on and manage regulatory exam activity and results
Proven skills in leadership, including strategic planning
Excellent drafting skills, this individual must be a highly articulate and effective communicator, especially in writing
Superior collaboration, team-building and relationship management skills ·
An ability to lead and influence people across cultures at a senior level using sound judgment, successful execution of strategies and with an understanding of how to operate effectively across diverse businesses
Poise and clear-headedness in challenging situations
Proficiency in MS Word, Power Point and Excel
Bilingual in English/Spanish Required, Portuguese a plus
Strong interpersonal skills for interfacing with all levels of Compliance management
Communicative, a problem-solver with a willingness to explore and structure areas that may be outside of area of expertise
Valuing diversity, demonstrates an appreciation of a diverse workforce and appreciates differences in style or perspective and uses differences to add value to decisions or actions and organizational success
BS/BA degree and 10+ years’ combination of education/experience in the financial industry or a control function
JD preferred, not required
Fluent in English and Spanish, Portuguese preferred but not required
Intermediate level experience in a related role with experience in business, function, and people management, with proven abilities in taking responsibility for issuing to stakeholders high quality deliverables according to strict timetables
Leading small to medium sized teams in a control/compliance function is required

Audit & Regulatory Lead Resume Examples & Samples

Establish and maintain globally consistent processes for all GSO Audit and Regulatory activities and engagements, in accordance with firmwide standards and GTI Risk & Controls guidelines
Lead GSO efforts in preparation, engagement and remediation of all GSO-targeted and cross-impacted Audit and regulatory activities, including internal audits, external audits (e.g. Price-Waterhouse, Ernst & Young), regulatory and external audit testing activities (i.e. SOX, SSAe16, MAS, etc.)
Maintain good communication between the GSO Audit & Regulatory function, GSO operating areas, the GTI Risk & Controls group, Corporate Technology & Risk (CT&R) and the Technical Control Officer (TCO) community globally
Provide comprehensive and timely support to all internal/external identified Audit & Regulatory issues and reporting
Expertise in the Audit & Regulatory environment including risk identification, control evaluation, testing, sampling methodologies, audit engagement process, controls substantiation, etc
Functional lead and/or related team management experience
General technical understanding of the various platforms, networks, and applications that comprise the Infrastructure environment, within the following risk domains/technologies
Network Architecture
Wintel/Unix/Mainframe
Database Security
Access Administration/Access Recertification/Privileged Access
Problem/Incident/Change Management

Risk, Regulatory & Control Lead Resume Examples & Samples

Manage the development of robust policies and controls for Information and Records Management activities Bank-wide, including Bank-wide Records Management and Archiving policies at all levels
Work with the GIRM core functions (Records Management, eDiscovery Operations, and Archiving) to ensure subject matter expert engagement in the development of policies and controls
Work with the Information Resiliency and Risk Management function (as the 2nd Line of Defense, within the Chief Risk Office) to develop risk appetite, control frameworks, governance, and reporting for Records Management and Archiving Risks in the Bank
Oversee the Chief Technology Office (CTO) eDiscovery Operations Risk & Control function
Manage resolution and reporting of GIRM obligations for internal and external regulatory findings and audit issues
Represent GIRM in the CTO RRC management group and manage GIRM’s relationship with the COO Divisional Control & Regulatory Office
Support “Run the Bank” governance structures, including Records Management and Archiving Committee (“RMAC”) and other relevant councils and steering groups, including acting as the coordinator and/or Secretary for RMAC and maintaining all GIRM approved governance body Terms of Reference (ToRs) and membership
Coordinate escalations from GIRM governance bodies to Records Management and Archiving Committee including escalations from CTB governing bodies
Develop and manage the reporting of GIRM obligations to Bank-wide initiatives
Liaise with CTO RRC, - Divisional Control & Regulatory Officer (DCRO), and others on the Risk and Control Assessment of GIRM’s “owned” activities including identification of controls to address material risks and the assessment of design and operating effectiveness of controls
Strong experience in qualities and capabilities needed to assess, monitor, establish, and operate effective policies, controls, governance and risk management within a global organisation
Developing an innovative and effective culture of risk aversion and risk remediation in response to legal, audit, regulatory, and business requirements
Developing skills and awareness to manage risk within individual service areas, ensuring effective escalation, resolution and response to address changing business, regulatory and control requirements
A strong understanding and practical use of governance, reporting, audit / issue management in a major organisation
Keeping pace with the industry risk, regulatory and control outlook with changing business and technology landscape
Degree level education (or equivalent) from an accredited college or university (or equivalent)
Innovative, creative, articulate and able to work directly with a broad range of stakeholders
Highly driven and motivated

Cybersecurity Regulatory Audit Lead Resume Examples & Samples

Support deliverables pertaining to Regulatory & Audit engagements, including responding to inquiries, managing examinations, and providing substantiation material
Analyze and review communications process with regulators, collaborating with the firm's global Compliance organization
Understand the sensitivity of response and nature of what is provided externally
Support internal processes for management of Regulatory & Audit engagements, ensuring controlled, consistent responses and ability to meet regulatory requirements
Collaborate with Firmwide Cybersecurity colleagues and other internal teams, including but not limited to Legal, Compliance, Oversight & Control and management teams
8+ years of business experience, ideally including experience in the Financial Services and Technology Risk or related fields
Outstanding verbal, interpersonal and written communication and presentation skills, including demonstrated ability to interact with both technical and non-technical stakeholders
Strong organizational and time management skills; ability to manage multiple and conflicting priorities in a global organization, and to adapt in a fast-paced environment
Ability to develop and maintain strong partnerships with key stakeholders, and to work across LOBs and regions, balancing the needs of multiple organizations
Ability to both learn from colleagues and think outside the box

Risk & Controls Regulatory & Audit Lead Resume Examples & Samples

Execution of all external GTI cross impacted regulatory & audit exams; working closely with Corporate Technology & Risk (CT&R) counterparts in respective regions to solicit and respond to relevant questionnaires & RFIs
Provide local (EMEA) point of contact for all regional external regulatory & audit exams and follow-ups with local EMEA CT&R counterparts
Support the execution of the SSAE16; the firms adherence to Statement on Standards for Attestation Engagements – conducting quarterly testing cycle for GTI including coordination and execution of Request for Information (RFIs)
Provide management and executive reporting on progress on all external audits and regulatory engagements including SSAE16
Oversight and reporting for all GTI internal audits
Identify and executing areas of improvements across internal processes - increasing efficiency and productivity across the GTI Regulatory and Controls organization
Considerable experience working in Technology Risk & Controls management or Technology Audit functions
Considerable experience working in or with Infrastructure Technology
Strong organizational and structured approach to work - consistently execution focused and proven track record of delivery
Strong relationship management and liaison
Understanding of Statement on Standards for Attestation Engagements (SSAE16)
Experience in Technology Audit, Controls, Regulatory Management or Information Risk

Regulatory CMC Lead Resume Examples & Samples

30% Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies
20% Develop global CMC regulatory strategy for one or more investigational and marketed products
10% Collaborate with US & International regulatory colleagues in development of global CMC regulatory strategies
10% Provide CMC regulatory guidance to project / product teams
30% Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Bachelor’s degree in pharmacy, biochemistry, chemistry, biology or related pharmaceutical field
Minimum of 5 years of related experience within a pharmaceutical company, CRO or similar organization and with minimum of 2 years International/Global CMC regulatory experience in small molecule drug development and registration activities

Lead Analyst With German Medical & Regulatory Resume Examples & Samples

Support supplier evaluations by running RFI, RFP and RFQ processes in collaboration with Medical and Regulatory line function and/or the strategic procurement managers
Discuss and prepare content and structure of those evaluations according to the characteristics and needs of the business case in an independent manner
Consolidate and document the outcome for decision making by the line function and/or Medical and Regulatory strategic procurement
Assist to price analysis, vendor risk assessments and due diligence activities
Support new vendor onboarding and relevant system set-up activities in SIM,
Produce final contracts understanding content and business drivers with particular focus on protecting IP and freedom to operate (e.g. Confidentiality Agreements, Master Supply/Service Agreements, Work-orders and amendments)
Manage traffic of contractual documents to ensure timely and compliant execution
Negotiations of smaller business cases and contract terms below defined value threshold
Ensure agreements are commercial advantageous to Novartis while minimizing risk through close collaboration with functional partners such as legal, finance, and QA
Consolidation of supplier-, market-, category- and internal business data
Supplier performance measurement processes collecting and assessing KPI’s and consolidating them in supplier performance dashboards
Supporting the buying process executed at line-function level by acting as a gating and/or coordinating role
Resolve Req-to-Pay issues
Participate in initiatives to drive functional objectives
University degree, CIPS or similar commercial qualification
Fluent German and fluent English
2-3 years procurement experience in the area of scientific services
Broad understanding of the technical development process and robust understanding of the impact to commercial production
Ability to think strategically and visualise future business needs
Demonstrated ability to make decisions and take responsibility for actions
Ability to address issues assertively in a respectful and appropriate manner
Excellent interpersonal skills with a proven record of business partnering
Ability to work in a complex, multi-cultural, matrix, international environment

Regulatory Labeling Strategy Lead Resume Examples & Samples

Mentoring employees/consultants
Interviewing and training employees/consultants
Minimum of 8 - 10 years of regulatory experience in the pharmaceutical/biotechnology industry
Expertise in developing CCDSs
Ideally, expertise in EU and US labeling requirements/ guidance for legacy and PLR labels and ability to communicate and resolve issues during labeling reviews and discussions
Understanding of SPL formats, requirements and guidance for legacy and PLR labels Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation
Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills
Excellent analytical, technical and problem-solving skills
A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach
Has demonstrated some leadership ability
Ability to manage somewhat complex projects and timelines in a matrix team environment
Ability to effectively present information to senior management, regulatory authorities, public groups and other departments
Ability to understand and interpret global regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines
Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook
Strong interpersonal and organizational skills
With some guidance, ability to evaluate issues relating to interpretation of scientific and clinical data and devise strategies to develop and maintain labeling to deliver corporate goals for new and mature products
Ability to implement company policy
Maintains knowledge of current regulation, guidance and enforcement and communicates changes within regulatory and to cross-functional teams
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
Domestic and international travel may be required for this position
Approximately 10% travel is required

Global HR Lead-regulatory & Government Affairs Resume Examples & Samples

Gain a clear understanding of current and future business strategies in order to define and implement effective people strategies
Develop and implement talent strategy that is aligned with the business needs of the Global Regulatory and Government Affairs organization over the next 3-5 years
Demonstrate active leadership during organizational change efforts
Manage the talent pipeline for Global Regulatory & Government Affairs by ensuring development of future leaders and successors for key leadership roles
Develop effective coaching relationships with key business leaders
Apply HR knowledge and skills to effectively drive business practices and resolve people issues
Providing ongoing coaching and consultation to people managers
Foster accountability for employee development and performance by ensuring training/goal - setting and recognition plans/programs are in place
Ensure effective leadership and operational excellence of all HR processes including performance reviews, incentive planning and talent reviews/succession planning
Provide counsel and assist employees and people managers in resolving complex or controversial Human Resource problems, including disciplinary counseling, legal issues and terminations
Assist in developing and implementing diversity and people development efforts
Bachelor's Degree in Human Resources or related field required. MBA or Masters degree in Human Resources, Organization Psychology or related field preferred
10 years of progressive Human Resources experience, previous HR Generalist experience preferred
Functional knowledge of HR laws, policies, practices and programs
Previous management or leadership experience
Solid understanding of HR policies/procedures, as well as local, state and federal employment laws
Able to maintain and build trust along with the demonstrated ability to protect and preserve confidential information
Flexible and able to respond quickly to changing job demands and prioritize multiple responsibilities
Recognize, respect, and leverage talents, skills, and resources of other, both in and outside Monsanto
Strong communication and presentation skills including the ability to communicate effectively with employees at all levels
Strong interpersonal, leadership, and project management skills
Ability to analyze information and make decisions quickly and accurately
Strong business acumen and ability to translate business needs to talent imperatives
Strong influence skills and demonstrated ability to work with leadership and employees
Ability to successfully collaborate with a network of stakeholders in a matrixed organization and build strong relationships with colleagues across functions and world areas

Risk & Controls Audit & Regulatory Control Lead Resume Examples & Samples

Coordinate the GTI SO activities for audit and regulatory engagements
Bachelor's degree in Computer Science, Management Information Systems, Accounting Information Systems, or a related field is required
Experience within financial services areas is preferred
Relevant certifications include: CISSP (Certified Information Systems Security Professional), CRISC (Certified in Risk Management) and CISA (Certified Information Systems Auditor)
Excellent analytic and problem solving skills, positive self-starter with proactive approach and excellent time management and prioritization skills

Nonclinical Regulatory Submission Lead Resume Examples & Samples

60%
Manage/Lead preparation, writing, review of nonclinical components of regulatory submissions and all technical documents for which the department is responsible. Ensure timely delivery of high quality, submission-ready submission components that are consistent with relevant regulatory guidelines for global submissions (eg, US FDA, EMEA, PMDA, ICH)
30%
Collaborate effectively with relevant stakeholders, intra- and inter-departmental functional representatives and submission teams in coordinating development, review and hand-off of nonclinical sections of regulatory filings and clinical bioanalytical content to Regulatory Ops/Affair, Clinical Ops/Development/Medical Writing
10%
Develop and maintain documents templates and high quality systems for tracking of nonclinical components of regulatory submissions, nonclinical technical and nonclinical & clinical bioanalytical reports and related nonclinical/clinical bioanalytical sections/content for global regulatory submissions

Lead, Regulatory Advertising & Promotion Resume Examples & Samples

Provides expert regulatory evaluation of proposed promotional and disease state materials for assigned products. Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, and assesses consistency of proposed claims with FDA-approved labeling. Serves as the chair of CMLR meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved
Ensures consistent review standards within the EAS system are upheld, and business needs are assessed and addressed. Works collaboratively with colleagues in A&P, Medical, Legal, Commercial, and Compliance to achieve alignment. Provides consistent, well-supported, and clear guidance to key stakeholders
Supports metrics to measure and track the effectiveness and efficiency of the CMLR process, provides recommendations for process improvements to address issues, gains agreement of process improvements from key CMLR-stakeholders, and implements agreed upon process improvements
Collaborates with the International A&P review teams for materials that are intended for global audiences
Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of enforcement trends. Participates in the preparation and review of comments to FDA’s docket regarding Federal Register Notices that may impact the organization’s promotion of commercial products
Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products
Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred
5+ years experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 2 years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered
Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products
Expert understanding of FDA regulations and guidance regarding advertising and promotion of prescription drug and biologic products
Demonstrated interpersonal skills with ability to demonstrate strategic and analytical thinking
Ability to work successfully with a cross-functional team
Ability to work independently, take initiative, and complete tasks to deadlines
Drives accountability and responsibility that enables others to act with integrity

Lead for Regulatory Program Resume Examples & Samples

Delivery
Deliver the e-Risk feeds for derivatives business line scheduled for Calendar Year 2016
Deliver Octon deliverables which is part of Calendar Year 2016
Design and Deliver the Report Matrix and integrate it with Batch Monitor which will provide daily status of all the reports and their progress to RTB in Batch Monitor for them to take corrective action
Support for strategic platform like Cash Architecture, STAR, etc., and making sure the Risk Regulatory Reports are not impacted
Support any adhoc/legal inquiry from internal/external regulators/Traders globally
Convincing and Assertiveness
Formalize and Explain the requirements to the Users and make them Understand the Data Model and the thought Process
Constant interaction with Senior members from Equities Derivative Risk & Regulatory Users related to RAMP/Octon or any new flow onBoarding to data warehouse
SME for RAMP/Octon requirements and firming up the functional requirement to meet the requirements
Control
Ensure that the release cycle of Dev to SIT/UAT to Prod is followed for all report releases
Ensures the usage of SVN processes to maintain different versions of the code
Strictly adhere to Barclays Change Management standards and ensure that every change goes through the rigorous change management protocol before being released to production
Functional/Technical Expertise
SME for Netezza, Informatica and ensure that the knowledge is imparted to RTB for them to manage RAMP/Octon Report/Feed Process jobs
SME for Equities Cash and Derivatives Risk Business domain
Assist the core lead and RTB in the region in Netezza Space Management
Work on application upgrades when there are hardware upgrades related to Netezza/Informatica
Point of Contact/Service
US Lead Developer for the Equities Data warehouse Regulatory program
Complete ownership of resolving any Prod issues for OATS, Bluesheets and other reports
Working with internal/external regulators, and legal at times for any demanding regulatory inquiries
Core member and wears multiple hats related to Data warehouse regulatory reporting items, as well as Core data warehouse activity
CTA Initiatives
Contribute to Big data CoP
Learn new Big data technologies like Hadoop, Pig and develop process for Star Schema Loading and generation of Gross Exposure monitor & other Risk Regulatory Reports
Stewardship
Optimize the Core Data load process and reduce the Data load and Feed generation time and add controls to ensure that Report is sent with complete data set
Come out with a Strategy on Improving the RTB alerts process by putting all the email alerts to Batch Monitor for all the reports generated and ensure that reports are delivered on time
Automate Data Quality Reports to monitor the matching ration between data warehouse and Risk Numbers to make sure the Risk Regulatory Reporting is top notch and avoid any gaps
Bachelor’s/Master’s Degree
Total of 14+ years of experience
7+ years of Data warehouse Experience
7+ years working on Netezza/Qlikview and related BI technologies
Data warehouse methodologies experience is mandatory (Ralph Kimball preferred)
Informatica experience is mandatory
Experience using relational database systems (Oracle) – database modelling, engineering, optimization is mandatory
Strong query writing skills
Netezza experience is mandatory
Netezza stored procedure experience is mandatory
Equities Derivative Risk & Product Understanding is mandatory
Unix scripting know/how is mandatory
RainStor experience is good to have
Cash Equities experience is mandatory
Strong analytical and problem-solving abilities, should be able to multitask and switch gears quickly
Use of tools that will expose data to users via a web based interface

Regional Regulatory Lead Resume Examples & Samples

Knowledge of the European and Global regulatory environment and how this impacts regulatory strategy and implementation
Knowledge of drug development practice, rules, regulations and guidelines
Strategic and analytical Thinker
Understanding stakeholder needs
Team working
Strong quality and compliance orientation
Change agile
Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences
MSc, MBA or PhD may be an advantage
Prior experience in the pharmaceutical or related industry in Regulatory Affairs, Conformance or Compliance
Strong knowledge / background of EU regulatory procedures and requirements
Experience in regulatory affairs or compliance preferably in human medicines - minimum 5 years of experience
Demonstrated regulatory experience with a pharmaceutical company with proven examples of contribution
Proven ability to manage Regulatory issues and consistently deliver to time, cost and quality standards
Regulatory experience including knowledge of Europe submission product lifecycle management processes
Demonstrated experience of effective delivery in a matrix environment

Senior VP-regulatory & Internal Audit Management Lead-aml Optimization Resume Examples & Samples

Lead the team that will respond to regulatory and IA inquiries on behalf of the SD&E team, by formulating and reviewing technical and SME responses, preparing reference materials and keeping a track-record of the communication. Represent the SD&E function during regulatory, IA and Compliance testing exams and reviews. An essential part of the candidate’s responsibility will be to capture key points of the official regulatory/IA meetings to assure that any questions, decisions, conclusions and agreed actions are recorded, and distribute notes to relevant parties and stakeholders as necessary
Partner with owners, developers, SMEs and users to ensure that documentation and responses are provided to the highest standards and in a timely manner
Perform quality control of the documentation and procedures and provide feedback to the SD&E management and teams where gaps or issues were identified; make sure that appropriate corrective actions are planned in the team
Work actively to improve the methodology and approaches, reflective of and in-line with regulatory expectations and feedback received
Maintain knowledge of the current methodology, policies, standards and procedures in SD&E as well as those related to Regulatory Exam Management or interaction with IA
Communicate the upcoming exams and IA validations to the wider SD&E team to assure awareness and readiness to support
Assure appropriate capacity exists in the team to meet the regulatory or IA response timelines and escalate to SD&E management any issues related to those
Master degree in a quantitative subject and/or experience in Internal Audit, Risk & Control or Model Validation field is necessary
Minimum 10 years of financial services industry experience with 3+ years of DIRECT experience with AML/BSA programs and Transaction Monitoring knowledge
Demonstrated ability to communicate effectively, both orally and in writing, through all levels of the organization and through different business units
Good understanding of end to end AML processes, people and systems including the standards of AML tuning across the industry including statistical techniques (e.g. statistical sampling, logistic regression, decision trees, etc.)
Experience in working as IA executive or in a function with exposure on IA/Regulatory reviews
Ability to manage competing demands and objectives without compromising timelines and the quality of output; attention to details with understanding of bigger picture

Regulatory & Policy Advisory Compliance Lead Resume Examples & Samples

Project management of significant regulatory matters, including enquiries, investigations, exams and regulatory change implementation
Build and augment the local implementation of Citi’s Global Conduct Risk Program
Preparation of materials to be reported to country governance committee meetings and to the Regional Compliance team
Manage regulatory change management processes and tracking system
Manage the Compliance team’s core policy requirements as a department
Manage documented second line challenge of significant first line processes in accordance with local regulatory and global policy expectations
Supervise the Regulatory and Policy Advisory team’s partnership with regional colleagues concerning core policy escalations
LI-W
Bachelor’s Degree or higher or equivalent work experience
Significant experience with governance, risk or control environments: implementation and management of frameworks
Comprehensive understanding of Australian banking regulations and frameworks
Strong understanding of the regulatory environment, in particular in the financial sector in Australia
Extensive business experience, preferably in the financial services industries
High level of cultural awareness and ability to sensitively adjust delivery style to appropriate audiences and stakeholders
Proactive, self-starter, ability to take initiative, take lead to devise creative solutions
Demonstrated ability to meet project objectives and deadlines
Persuasive and influential communicator. Excellent interpersonal and communication skills
Strong organizational and follow-up skills and the ability to multi-task effectively in a high-volume environment
Team Orientated with a collegial approach to addressing challenges
Ability to work in a team of diverse skill sets / cultures
Ability to remain calm and objective in a high-pressure environment

Global Regulatory Team Lead Rare Diseases Resume Examples & Samples

Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team and provides regulatory input for the project(s) globally. In this capacity, the GRL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL will work closely with members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross function project team meetings on an agenda driven basis
The GRTL will ensure development of robust regulatory strategies for the program and will be accountable for developing and maintaining a regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development, but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy
The GRTL is accountable for ensuring that all GRA peer reviews are conducted in a timely manner ahead of key governance meeting and major (issue driven) ad hoc reviews by Sr. Management. The GRTL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels
The GRTL, working with the regions, will also interact directly with HAs as needed for the project
The GRTL will work transversally to ensure a properly functional Global Regulatory Team and provide an environment and venues under which all GRA team members and functions have a voice
The GRTL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed
Assess the accuracy and appropriateness of submissions to regulatory authorities to support successful clinical trial applications and/or marketing authorizations
Provide regulatory due diligence assessments of new business opportunities as required
Depending on the program assignment, GRTL may also serve as the US Regulatory Lead and responsible for developing and implementing the US regulatory strategy. The US lead will serve as the primary FDA contact as needed and will represent the US regulatory position to senior management governance committees as needed
7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Experience in other relevant functions will be considered. BS in a scientific discipline
Strategic
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
Excellent operational skills including planning, organizing and ability to motivate and lead others
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-SA

Oncology Global Regulatory Team Lead Resume Examples & Samples

Represents Global Regulatory Affairs (GRA) as a member of the cross functional project team. In this capacity, the GRTL is the single point of contact for the business and R&D on regulatory issues for the project. The GRTL provides regulatory advice and strategy for the project(s) and ensures timely execution of regulatory activities
Manages the Global Regulatory project subteam(s). Ensures effective communication between cross functional project team and regulatory subteam; oversees planning and execution of global regulatory activities and submissions
Ensure development of robust global regulatory strategies for the program and is accountable for developing and maintaining a regulatory strategy document. The regulatory strategy addresses the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRTL will work with the global regulatory subteam to ensure relevant input from all GRA functions is vetted and included in the regulatory strategy
Responsible for developing regulatory strategy information for presentation during leadership governance meetings. The GRTL is accountable for ensuring GRA Sr. Management alignment with strategy, risks and mitigation and for presenting a unified regulatory voice
The GRTL is responsible for ensuring communications from HAs are disseminated in a timely manner and properly interpreted, to the project teams, the business unit, and GRA Sr. Management
Provide regulatory due diligence assessments of new business opportunities as required
7 years pharmaceutical industry experience in R&D, Regulatory or related functions, with at least 5 years working in regulatory affairs (regionally or globally). Regulatory lead experience in US or EU. BS in a scientific discipline
Strategic
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
Excellent operational skills including planning, organizing and ability to motivate and lead others
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the Global and U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values #LI-GZ

IT Risk & Controls Audit & Regulatory Control Lead Resume Examples & Samples

Receive and validate engagement requests for information
Assign requests to appropriate service areas within GTI SO for fulfillment
Track and monitor the status of all requests, escalating as appropriate to ensure SLA adherence
Communicate with key stakeholders, providing accurate metrics and management reports on timely basis
Provide strategic drive for engagement efficiency and effectiveness improvements, including process enhancements and use of automated data collection techniques
Audit & Regulatory

Regulatory Team Lead, Publishing Resume Examples & Samples

Degree in pharmacy, chemistry, biotechnology or related science
Proven ability to successfully lead a team in a time sensitive work environment
Minimum 5 years of experience in Regulatory Affairs
Documented managing skills
Analytical mind and problem solving skills
Strong sense of urgency and ability to prioritize work
Effective communication skills in English and Polish

IT Regulatory Program Lead Resume Examples & Samples

Work with the technology Business Analyst lead for GDPR to develop a clear framework to manage the GDPR program, including (but not limited to) govenance communications, meeting schedules, stakeholder matrix, accountabilities and awareness
Develop a clear project plan for the GDPR planning, communication, execution and remediation of the requirments
Work directly with the technology Business Analyst lead for GDPR to understand the tasks involved, engagments required and dependencies as well as risk
Develop reporting structures and format for communication on the project
Project Governance – Provide reporting on the progress, track and monitor progress and maintain an issue tracker to document key issues and risks
Ensure awarenss of other regulatory change programs and contribute to the global agenda on this
Ability to communicate clearly both verbally and in writing to generate and maintain support for challenging goals that optimize performance
Flexibility and initiative to see and then seize emerging opportunities, as well as the passion to inspire others to pursue them
Confidence to interact with all levels of management in the Tehnology and at a firmwide level
Ability to lead matrix teams to achieve genuine momentum and progress
Prior experience of working in the regulatory function for Financial Services or other large organisation
A good awareness of EMEA regulations with specific interest in Technology / Security for the Financial Industry
Prior experience in one of the following control/risk related functions
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
Strong diversity skills – ability to communicate effectively with people from various regions, countries and religious beliefs
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

Operations Lead Product Safety & Regulatory Business Resume Examples & Samples

The role acts as prime interface to Finance and R&D Portfolio
Knowledge of an R&D organisation and how it operates
Project and portfolio management knowledge to balance expenditure in a complex organisation
Be able to demonstrate effective problem solving, communication and negotiating skills
Proficiency in budget and function management
Facilitation of work teams and meeting management skills
Demonstrated ability to successfully influence colleagues across functional boundaries
Demonstrated ability to communicate complex situations/solutions effectively to non-experts

Regional Regulatory Lead Resume Examples & Samples

Regulatory principles
Working with policies, procedures and SOP’s
Knowledge of national legislation and regulations relating to medicinal products
Awareness of the registration procedures in region for MA, post approval changes, extensions and renewals
Knowledge of drug development

Cib-cfs Complex Change Prod Dev Lead Regulatory Resume Examples & Samples

Programme/Project management & delivery of complex Change Projects in Custody and Fund services – those of significant scale, complexity & budget and that are generally mandatory in nature (e.g. Regulatory)
Commercial Awareness: To understand the commercial impact of implementing regulatory change across the business and client base, our competitors and the market
Display market knowledge and insight into existing and pending changes in regulation and how different lines of business could be impacted
Opportunity identification: To identify service offerings & revenue opportunities that may be created by Regulatory change, and identify overlap/synergies with the strategic change agenda so as to advance the strategic goals of the Product Development group
Identify and process improvements in the end to end Regulatory project framework
Leadership: Leadership across the separate business and functional groups –driving progress, bringing coordination and coherence
Accountability: Ultimately accountable for project delivery – programme definition and execution
Design - delivering well-designed end to end solutions, automated, simple and stable, from first point of instruction capture through to integrated rate card adjustments and billing system updates
Governance: To instill clear governance models for change programmes, across business lines and functional partners
Client-facing: To be the ‘face of the firm‘ to clients on joint JPM/Client Regulatory Programmes of work
Controls: Ensure appropriate adherence to Risk and Control policy
Minimum 6 years experience of Banking and Financial Services
Broad-based business knowledge across the full CFS product suite, with deeper knowledge in one of Custody or Fund Services
Excellent written and oral communication, clarity of thought and the ability to express oneself clearly
Drive and determination – leading, influencing and driving multiple programme contributors to meet overall project objectives
A problem solver with the ability to see the big picture across lines of business, as well as being able to step in to understand the detail to help resolve issues as and when required
Strong track record of project delivery, and good project discipline
Proven good judgment , particularly on prioritizing your own and others’ workloads – including managing multiple deliveries simultaneously
Self-motivated, quick learner, being the focal point of a virtual project team, comfortable with responsibility
Being able to build relationships across teams
Client facing experience
Knowledge of the regulatory landscape for Custody and Fund Services
Experience with system and process design, Target Operating Models

Global Regulatory Lead-neurosciences Resume Examples & Samples

25%
Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision making teams such as PSTs and GDTs
Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies
Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects
Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings
Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image
Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities
Provides guidance to all appropriate departments in Shire to assure compliance with applicable regulations
Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed
Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to Shire staff
May supervise a changing number of Regulatory Affairs Associates
Minimum of BS degree in scientific field required; MS, MSc, PhD, PharmD, J.D., or M.D. in science or healthcare preferred
Generally has at least 5-10 years of Regulatory Affairs or equivalent experience. The regulatory experience should be broad to ensure appropriate leadership and mentoring for regulatory staff within Shire

Regulatory Product Lead Resume Examples & Samples

Science degree in a biological science is required. Advanced degree (M.D., PhD, or Pharm.D.) preferred
Minimum of 8 years in drug/biologics development in the US pharmaceutical and biotechnology industry or Government Health Agency
Demonstrated track record of successful management of submissions in US regulatory affairs is required. Prior regulatory agency liaison experience is preferred
Experience in biologics, drug safety, pharmacovigilance and/or risk management preferred

VP, Official Risk & Regulatory Lead Resume Examples & Samples

Requirements analysis and capture, working closely with business users and managers to scope and define solutions
Applying a deep understanding of Rates financial products to help drive the full development lifecycle (especially planning, analysis/design, testing phases, but also tracking and advising the development phase)
Previous 3+ years of work experience in Simpliciti's enterprise Risk Platform
Proven ability to lead developers in a team environment
Understanding of Agile software development methodology
Has effectively specified and driven solutions to business problems
Rates derivatives trading products Skills
Derivatives official risk knowledge
Primary technical skills: C#, SQL. Python
Secondary technical skills: HTTP/APIs, Excel/VBA, MDX Query
Ability to apply sound technical skills and knowledge of the Rates business to develop creative solutions to meet client and business needs
Ability to develop strong relationships with others, effectively influencing peers and business partners
Excellent communication skills, oral and written Qualifications

Global Regulatory Lead, Development Products Resume Examples & Samples

Minimum of 10 years’ experience in the biotech or pharmaceutical industry, with at least 8 years in Regulatory (with 5+ years of that time in a developmental stage organization)
Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment
Candidates must have thorough knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (ie. EU, US, Japan)
Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment across two or more geographic areas (preferentially US and EU)
Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
Demonstrated experience in working with multiple stakeholders
Prior clinical regulatory foundation and/or management experience is preferred

Global Seed Health Regulatory Lead Resume Examples & Samples

Develop a Global Regulatory Phytosanitary Information Management strategy, contemplating cross functional needs of data and knowledge repository
Establish and provide leadership of a Seed Health Strategy Team, in order to effectively prioritize resource allocations and programs developments
Create and lead Global Cross Functional teams to develop or implement seed health strategies and programs; ensure Monsanto Global Seed Health guidelines and best practices are developed and implemented across functions, help develop Monsanto positions on Seed Health policy
Act as contact and source of information for diverse Phytosanitary change management initiatives
Develop and support functional development of seed health accreditation strategies
Provide regulatory leadership and coordination for current initiatives (Post Entry Quarantine in Brazil, NSHAPP, others) and propose opportunities for improvement
Be an active member of the Global Seed Regulatory network, assuring proper representation of regional needs and interests as global strategies are designed
Graduate degree or a B.S. with appropriate experience in scientific discipline required in addition 5+ years of experience in seed, agricultural, agbiotech, or chemistry industry
Strong knowledge of Monsanto functions and a strong understanding of the impact seed Regulatory has on business success
Demonstrated ability to influence others to achieve a desired outcome
Demonstrated strong networking skills, ability to manage international stakeholders
Excellent people skills, able to work effectively with wide range of functional groups and with seed regulatory leadership team
Balanced attention to detail with broader scale objectives
Process oriented, familiarity with quality management systems is desired

Regulatory Science Lead Resume Examples & Samples

A BSc/ Master’s degree in a relevant Life Sciences discipline
At least 5 years’ experience (min 5-10 years for the Regulatory Lead) in pharmaceutical regulatory affairs working with cross-functional and international teams
Knowledge and experience of EU regulatory procedures and legislation related to drug development, product registration, line extension and/or license maintenance
Proven successful contribution to delivering regulatory approvals (Regulatory Lead)

Regional Regulatory Lead, Senior Manager Resume Examples & Samples

Executing the approved regional strategy for assigned programs
Representing the region
Advising the GRT on regional considerations in developing strategy
Ensuring the regional needs are well defined and implemented in collaboration with relevant regional stakeholders
Regulatory knowledge in national regulations
Experience with national legislation and regulations relating to medicinal products
Understanding of the registration procedures in region for MA, post approval changes, extensions and renewals
Understanding of drug development

Global Regulatory Lead-development Products Resume Examples & Samples

1) Responsible for developing and advocating for scientifically sound core regulatory strategies (clinical, non-clinical, & CMC) that result in successful regulatory submissions and approvals for assigned project(s), with a primary focus on product life-cycle management
2) Leads the Global Regulatory Affairs Strategy Team (GRAST) by
Leading the development of the global regulatory strategy, e.g., Global Regulatory Strategy Outline (GRSO). Proactively adapts the strategy to ensure new information is incorporated and includes start-of-the-art regulatory intelligence
Ensuring regional engagement in global regulatory strategy development and execution
Resolving internal GRA boundary inputs for GRAST members
Utilizing appropriate departmental tools to consistently run and execute GRAST meetings
Prioritizing global regulatory submissions based on team input
3) Supports regulatory agency meetings, regulatory advisory committee meetings, scientific conferences or equivalents
4) The GRL advocates and drives the ‘one GRA’ perspective with team stakeholders. The GRL also provides regulatory leadership and perspective into the labeling development and maintenance with the support of the GRAST
5) Reviews and approves internal and external documentation to support the development and commercialization of responsible product(s), including protocols, development safety update reports (DSUR)/ Product Safety Update Report (PSUR), annual health authority updates, clinical trial applications (CTA) / IND amendments, CTD documentation and post-approval change documents
6) Leads the development of regulatory plans, risk assessments and strategies, pertaining to the assigned project(s) and presents to senior review committees such as GRA Strategy Management Review Team (SMRT), and others as appropriate
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory
Has experience working in matrix teams, and ideally, experience of effectively leading matrix teams
Candidates must have awareness and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in at least one key region (ie. EU, US, Japan)
Experience working within the regulatory affairs (regional, clinical or CMC) in a global environment
Demonstrated experience in working with multiple stakeholders, across geographies

Regulatory Product Lead Resume Examples & Samples

Capable of managing multiple projects and complex timelines in a team environment
Excellent interpersonal, communication, analytical and organizational skills. Good negotiation skills essential
Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
Ability to work in a highly matrix working environment is important given the need to interact effectively with other GRA functions, internal departments and external organizations

Regulatory CMC Lead Resume Examples & Samples

Serve as a liaison between the regulatory authorities and the company on CMC issues
Provide CMC RA leadership within RA and on cross-functional CMC teams
Serve as a liaison with regulatory authorities for products in the area of Chemistry, Manufacturing and Controls (10%)
Provide CMC regulatory strategy for proposed changes, new development efforts, content message points, or other related activities, for commercial and/or development programs. (50%)
Facilitate timely regulatory approvals of new drugs and life cycle activities by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%)
Lead other development functions for timely preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%)
Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)
B.S / M.S / Pharm. D. or Ph.D. in biochemistry, biology, engineering or related pharmaceutical field
At least 7 years of drug development/pharmaceutical industry experience (or equivalent) including significant strategic experience (5+ years) in CMC regulatory affairs (or equivalent) with a small molecule and/or biologics background
Demonstrated leadership in regulatory strategy and experience in regulatory interactions

GTI Asia Audit & Regulatory Lead Resume Examples & Samples

Ensure complete, timely, accurate responses are provided for GTI impacting internal audits and regulatory exams. Liaison with support teams and required Service owner groups to collate responses
Provide subject matter expertise on RFI management, issue discussion with audit, issue & action plan owner identification
Review/Clarify Audit RFI’s & issues raised
Drive escalation of relevant issues into global & regional forums
Execute focused service specific control assessments in response to regulatory requirements / industry events (ex: breaches)
Drive continuous improvement within the audit & regulatory processes by leveraging material re-use, staff training, etc
Drive assessment of thematic issues within the environment & appropriate next steps
Provide Governance & Oversight on GTI Audit / Regulatory remediation projects with a view to ensure a) consistency and transparency & b) ensuring the intent of the remediation / findings is resolved
Partner with central GTI teams Or Technology Controls organization to a) provide inputs into development of new risk & control tools, b) support / drive process or tool related improvements as required
Establish effective engagement & collaboration with GTI Regional & Global control leads & stakeholders to drive issue remediation / other any requirements
Enable metrics + reporting for Internal and Regulatory exams
Identify areas of improvement and oversee activation of remediation steps
Comprehensive understanding of IT control policies
Minimum 4 - 5 years of information technology risk management experience
5-7 years of work experience in one or more areas of infrastructure is preferred with a broad understanding of infrastructure
Demonstrates a breadth and depth of operational risk & controls management expertise, preferably in an international environment
Ability to work independently and to tight deadlines
Strong development focus - advocate of developing employees, teams and the business
Significant experience of leading and managing teams (including matrix management) within an operational service delivery or shared services environment
Strong communicator at all levels
Strong written and verbal presentation skills to a wide variety of senior managers across the organization
CISM/CISA/CRISC certifications a plus

Chief Information Officer Regulatory Lead Resume Examples & Samples

Implementation and input into the CIB Technology strategy set by the Global CIB CAO, the Global CIB CIO and the EMEA CIO for the UK entities, as agreed by the legal entity boards and London Branch Oversight Committee. Develops where applicable to the UK entities, the CIB Technology function to adjust to local market developments within the overall CIB CAO strategy
Reviewing the financial performance of the UK entities’ CIB Technology function in line with financial plans agreed by the Global CIO, the Global CIB CIO, the legal entity boards and London Branch Oversight Committee
Ensures that there is an appropriate governance structure for the UK entities’ CIB Technology function
Taking reasonable steps to implement operational risk controls in the UK entities CIB Technology function, consistent with the Firmwide operational risk management framework and other risk appetite parameters. Where appropriate, takes into account input from relevant stakeholders on the likely impact of risk decisions on the UK entities
Communication of the firm’s culture and conduct standards in the UK entities’ Technology function
Raising to the EMEA CIO via the EMEA Technology Operating Committee (ETOC) and the UK Management Committee (UKMC), any material matter that is relevant to the control of the UK entities’ CIB Technology function. Responsible for the management and resolution of issues formally raised by Risk, Compliance and Internal Audit in respect of the CIB Technology function. Escalates to the business heads any Technology related issues that require resolution by them
Managing the administration and co-ordination of all matters relating to the CUTOC (CIB UK CIO is chair, secretariat lies with this function)
Maintaining an open relationship with the regulators
Batchelors Degree
Proactive approach to problem solving, owning the issues and having the determination to follow tasks /issues through
Experience and proven track record in stakeholder management, partnership and governance
Strong leadership skills at senior management level
Strong relationship building skills in a complex organisation

Technology Controls Regulatory Lead Resume Examples & Samples

Establish a regulatory engagement model for EMEA and related legal vehicles (e.g. CEP), leveraging Citi best practices
Develop a roadmap with a focus on emerging risks, themes, prioritization, local in-country and regional laws and regulations
Monitor and report progress of regulatory corrective action plans to senior management
Work with the Risk and Control teams to analyze latest technology scorecards, preparing executive summary reports for IT management to highlight emerging risks/concerns
Extensive years of experience in Regulatory Engagement and Internal Audit, Information Security or IT Risk Management discipline
Working experience with EMEA in-country laws and regulations
Awareness and execution of the Control Self-Assessments such as Managers Control Assessment (MCA), or other technology self-assessment processes is an advantage
Experience performing Internal and/or External Audit coordination
Experience in Production Support and Application Development roles
Ability to influence others and quickly earn the confidence of others
Quick learner and able to work in a diverse, global environment
Ability to coordinate/manage initiatives from end-to-end with minor supervision
Bachelor’s Degree Required

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