Regulatory Project Manager Resume Samples
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Regulatory Project Manager Resume Samples
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A Hand
Alberta
Hand
61853 Felipe Circles
New York
NY
+1 (555) 948 4661
61853 Felipe Circles
New York
NY
Phone
p
+1 (555) 948 4661
Experience
Experience
Los Angeles, CA
Regulatory Project Manager
Los Angeles, CA
Rodriguez Inc
Los Angeles, CA
Regulatory Project Manager
- Create and manage project work plans, issues, risks, and key decisions
- Present status of your work to senior management and stakeholders
- Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
- Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes
- Manage multiple work streams within complex regulatory projects
- Internally works in interface with RA officers in the RA centers and with regional maintenance & compliance manager
- Assisting in the development of new business with existing and new clients for the provision of regulatory service
Los Angeles, CA
FRC Regulatory Project Manager
Los Angeles, CA
Champlin and Sons
Los Angeles, CA
FRC Regulatory Project Manager
- Working closely with delivery partners in FRC IT and other areas of the bank
- Driving the development and implementation of the IB business strategy
- Coordinating objectives, scope, approach and plans with other initiatives to ensure alignment
- Managing stakeholders across the Rates & Credit Sales, Trading and support functions globally
- Leading the implementation planning in conjunction with FRC IT
- Managing the systems and processes of multiple change and remediation programs globally
- Keeping stakeholders informed of all aspects of implementation
present
Chicago, IL
Senior Regulatory Project Manager
Chicago, IL
Jast, Streich and Wilderman
present
Chicago, IL
Senior Regulatory Project Manager
present
- Serve as subject matter expert on regulatory change management topics
- Cost management
- Development and maintenance of key project artefacts, ensuring that GBIS project management lifecycle (PMLC) has been applied to projects and documents are drafted, reviewed and approved in accordance with the Change team guidelines
- Active management the project team, which may include matrix management of SME’s belonging to other support functions or business lines. Ensure that all tasks are adequately assigned and monitored
- Report on status and monitor the day to day execution of the programme using both local and Head Office reporting tools including PRIME. Progress reporting to the Head Office Steering Committee on a regular basis
- Support the development of processes within the Hambros PMO and champion the use and development of best practice tools and templates
- Develop comprehensive plans used are used as a basis to manage the project and present progress to senior stakeholders
Education
Education
Bachelor’s Degree in Business Administration
Bachelor’s Degree in Business Administration
University of Florida
Bachelor’s Degree in Business Administration
Skills
Skills
- Solid facilitation skills
- Continuous Improvement and knowledge sharing focused
- The ability to create agreement among differing stakeholder views
- Ability to analyze problems and recommend actions
- Knowledge of current Citibank current systems infrastructure, with emphasis in CFC, FRS, IRIS, REGIS, DREG, RDW (Regional Data Warehouse), SMART II, GENESIS and US RRI
- Strong Process Management Experience
- Process oriented with broad technology and regulatory knowledge
- Comprehensive knowledge of Citi reporting process
- Strong interpersonal, analytical, problem solving, negotiating, influencing, facilitation, prioritization, decision making, organizational as well as conflict resolution skills
- Ability to collaborate and negotiate with global lead peers in order to deliver the expected results
15 Regulatory Project Manager resume templates
Read our complete resume writing guides
1
Gwm-regulatory Project Manager Resume Examples & Samples
- Partneringwith senior management and cross-functional teams (e.g. front office, product,technology, operations, legal/risk/compliance) to assess current businessprocesses and determine improvements
- Identifyingweaknesses, gaps and opportunities for improvement and reporting the findingsin a simple, compelling way to influence the business to transform andchange the status quo
- Recommendingimprovements across all aspects of an operating model - redesign oforganizational structure, process efficiencies and technology enhancements
- Understandingbusiness requirements and prioritizing change requests
- Performinguser acceptance testing of newly built processes and solutions and guiding enduser
- Promotingand monitoring adoption of new solutions and business processespost-implementation
- Workingcollaboratively with team members and cross-functional groups
- Partner on end-to-end implementation projects including project management, execution and evaluation
- Prioritize alternative solutions, drive results and influence senior leaders in a cross functional, diverse environment
- Influence senior leaders and the business in a cross functional, diverse environment to transform and change status quo
- Work independently, and know when to ask for guidance
- Develop and translate quantitative analysis into strategy
- Effectively create and present oral and written communication
- Develop relationships and build a network throughout the firm
- Maintain a positive attitude and act as team player while delivering on high priority, time sensitive initiatives
- 4-7 years of experience in strategic consulting, management consulting, project management, process improvement
- Demonstrated ability to be an integral team member on large-scale, complex global projects (planning, designing, documenting, communicating)
- Bachelors degree from an accredited, high quality institution
- Strong PC skills (Microsoft Suite including Excel, Word and Visio)
2
GWM Regulatory Project Manager Resume Examples & Samples
- Developing effective partnerships with key business partners including the various Product & Asset Class owners, Business Management teams, Finance, Legal, Compliance, Tax, Risk, Marketing, and Technology & Operations
- Defining the scope and structure of the Program
- Developing the project plan and managing activities across all impacted functions in PB, including providing updates for senior management
- Conducting the initial feasibility analysis including the identification of roadblocks, budget estimate, infrastructure analysis, cross-business impact and resource assessment
- Aligning resources cross-functionally and globally where required
- Developing the end-to-end business and operating model with input from other functions
- Managing multiple and diverse stakeholders to achieve a successful conclusion to the overall Program
- Managing the interface with Technology and Operations to successfully deliver the Program
- Evaluating new and emerging industry and regulatory developments in conjunction with our Legal and Compliance teams from a business perspective to assess the impact on the existing business and operating model and product range including industry, regulatory, tax business and competitive changes
- Generally, implementing the delivery of any significant industry or regulatory changes across the domestic business, working across all functions of the Private Bank
- Minimum of7-10 years of experience in large-scale project planning and product
- Experience with and/or knowledge of a large asset management and/or private wealth management organization (preferred), including understanding of
- Asset Management and Investment Bank investment capabilities across asset classes
- Multiple operating platforms and processes
- Trading systems and middle/back-office process flows management
- Strong recommendations available upon request
- Candidate must enjoy working in a fast-paced and demanding environment and must be a strategic, conceptual and analytical thinker
- Excellent strategic influencing and interpersonal skills, comfort in working with people at all levels across all functions
- Excellent written and verbal communication and an ability to articulate complex ideas, concepts, and solutions at a level appropriate and intelligible to the recipient
- Detailed understanding of the systems & tools that drive the investments business
- Ability to develop effective partnerships with key business partners
3
Am-gwm Regulatory Project Manager Resume Examples & Samples
- Working with a range of functions across GWM to scope the nature of the regulatory, industry or business change required
- Establishing, leading and implementing the initiative (Program) required to deliver the change required across the U.S. Private Bank, including
- A broad understanding of securities, instruments and structured products, portfolio management techniques, investment processes, and investment management products
- Ability to think on their feet and be able to apply critical thinking and logical/structured framework to situations such as business case development and issue resolution
- Excellent in project management disciplines and an ability to instil structure, process, accountability, delivery and client-focus
- Global perspective
4
Regulatory Project Manager Resume Examples & Samples
- Manage the team to ensure activities are appropriately assigned and ensure that all deadlines are achieved
- Preparation of materials for working groups, steering committees and other ad hoc presentations
- Working with the business architects and IT, contribute to or defines the strategic direction for the relevant infrastructure and processes, aiming for a simplified, lower cost model, removing complexity, and delivering benefit to the CRO Organisation
- An Investment Bank and/or Asset Management and/or Consultancy background, with a strong understanding of structured project management within the Financial Services arena
- Either
- A proven track record in delivering results through the provision of a management consulting skill set
- Proven ability to communicate with all levels of Management in a clear, concise manner
- Essential
- University under-graduate degree
5
BPI Corporate & Regulatory Project Manager VP Resume Examples & Samples
- Provide Project Management & business analysis expertise for one or more projects
- Lead all aspects of Project, from requirements gathering to post project benefits review
- Escalate appropriately to management and/or business and technical sponsors
- Coordinate and facilitate meetings among key project personnel and ensure a proper framework for issue resolution and risk mitigation is developed and utilised
- Focus the goals of projects and analysis to ensure conformance to requirements and appropriateness of the delivered product/solution
- Demonstrated Project Management and Business Analysis skills with hands on approach, preferably within the financial services industry
- Work experience in the financial services industry. Familiarity with buy-side investment management process a plus
- Technical aptitude highly desired (e.g. SQL)
6
Regulatory Project Manager Dublin Resume Examples & Samples
- Objectives, scope and project plan definition and maintenance
- Deliverable execution, tracking, challenge
- Meeting organisation, management and recording
- Change control definition and management
- Assessment, tracking and management of constraints, assumptions, issues, risks and dependencies
- Risk mitigation and issue resolution
- Issue escalation
- Status tracking, reporting and presentation
- Project closure
- Challenge, training and supervision of other Project Managers
7
BPI Corporate & Regulatory Project Manager Resume Examples & Samples
- Work with the Head of BPI and his key leaders to support day-to-day responsibilities in such areas as business planning and reporting, team oversight, hiring and recruiting, and internal communications / presentationsProvide operational, analytical and business management support
- Prepare materials and present, as required, to senior business leaders
- Track and manage BPI projects from a resource perspective
- Support and execute process improvement initiatives across BPI to improve controls, mitigate risks, manage costs and increase efficiencies
- Support in the development, communication and execution of long-term strategic vision and targets
8
Regulatory Project Manager for Automatic Exchange of Information Resume Examples & Samples
- Develop a sufficiently deep understanding of the respective regulations to draw the right conclusions and put the different tasks into context
- Apply analysis skills and business expertise to translate regulatory requirements into fully compliant yet business-friendly implementation instructions
- Identify and manage issues, actions and project risk
- Manage working groups, coordination with specific locations and track status
- Run well managed, audit proof projects
9
Senior Regulatory Project Manager Resume Examples & Samples
- Analyze the impact of new regulations or changes in existing regulations on Wealth Management products and services globally
- Develop solutions that address regulatory requirements (including the design of business processes and policies) while minimizing the impact on the business
- Translate solutions into business and IT requirements and coordinate, lead and monitor their implementation
- Define the required organizational setup of projects, including the identification and nomination of relevant project stakeholders and committees
- Present status of your work to senior management and stakeholders
- Establish, lead or participate in interdisciplinary working groups and steering committees
- Develop subject matter expertise for regulatory topics and proactively inform stakeholders on the latest developments
- University degree in business administration, economics, law or similar
- A minimum of 5 years of relevant experience in a regulatory, compliance, or risk management environment in a bank, financial institution or consultancy
- Ideally you have combined roles as business analyst and project manager
- Proven conceptual expertise with ability to translate legal and regulatory requirements into business requirements
- In-depth financial product knowledge (e.g. funds, derivatives, structured products), preferably gained in Wealth Management
- Strong analytical skills with the ability to comprehensively and concisely document and present results to stakeholders
- Further education such as CFA, FRM, or SFA etc. is desirable
- Proficiency in Word, Excel, PowerPoint
- Preferably fluency in both German and English
- Excellent communication skills at management level
- Commitment to quality and timely delivery
10
Risk & Regulatory Project Manager Resume Examples & Samples
- Work closely with CCAR Central team and other CCAR teams such as PPNR, Aggregation etc. to ensure consistency of assumptions and processes
- Create CCAR compliance review and process control documents for approval by senior management. Identify risks and implements controls that lead to process efficiencies
- Work closely with Directors to provide insights on potential process gaps and suggest improvements to the same. Develop operations in a manner that is collaborative and consistent with the long term strategic plans for the business division
- Provide support in development of processes for identification of key macroeconomic variables and scenarios. Also assist the CCAR teams by ensuring they have the necessary data for their processes
- Provide the various processes across CCAR with the required business assumptions
- Provide support in ensuring that the output and results generated are consistent with the understanding of the B/S and PnL
- Bachelor's degree in Business, Accounting, Finance or Banking, or equivalent education and related experience
- Master's degree in Business, Accounting, Finance or Banking is desirable
- 7 years of progressively responsible experience in banking, investments, or financial planning
- High aptitude for relationship management and business development
- Good working knowledge of regulatory requirements (Basel III, IHC, CCAR, EPS)
- Highly motivated leader with proven track record of leading entire divisions
- Ability to balance multiple demands and work both independently and as part of the team
- Exhibits the following competencies, among others: teamwork and collaboration, focus on clients and risk management, sound judgment and decision making, integrity, professional behavior
- LI-VE1
11
Regulatory Project Manager Resume Examples & Samples
- Lead global extended project team across multiple business lines
- Manage multiple work streams within complex regulatory projects
- Represent project or project work streams or projects at governance meetings, budget planning and other project forums
- Provide appropriate status communication to governance forums, stakeholders and clients
- Partner with Legal and Compliance to determine the business impact of proposed regulations
- Accountable for the delivery of all phases of the project lifecycle
- Develop implementation strategies and project plans
- Develop budgets and resource plans
- Conduct detailed process analysis, develop business requirements and work with IT to translate these into functional specifications
- Develop test strategies and execute functional and user acceptance testing
- Develop control frameworks and integrate into existing compliance structures
- Manage project issue and risks with timely escalation where appropriate
- Build and leverage strong working relationships with key stakeholders and partners
12
Regulatory Project Manager Resume Examples & Samples
- Active participation in the definition of the new Regulatory US RRI Process rollout strategy across all centers
- Business leader in the Process documentation, design, specification, test and implementation of the new initiatives involved in the new operation model
- Leverage subject matter expert on business / project implementation issues related to the Regulatory process
- Define training strategy, oversee the design and training delivery for new users and users impacted by Full Suite or any new global initiative
- Work with users to resolve issues and maintain relationships
- Serve as a liaison between the Regional Leaders and other stakeholders within GPO and FRO teams
- Collaborate with peer global Regulatory Leaders to refine the model and system functionalities
- Interact with other Finance GPO component team leads to ensure integration, such as Data Quality, RRAI and BSS
- Assist the GPO Senior Management meetings and SDM meetings to present the execution status of the projects
- Ensure PMO discipline across all phases of the project. Ensure proper problem tracking and resolution during development, testing, and implementation in the Operational areas
- Assist in staffing and capacity planning functions for the FRO Regulatory team and review existing MOUs and Operating Charters
- Ensure metrics are in place for the Regulatory teams so we can operate through a cost-effective process
- Knowledge of current Citibank current systems infrastructure, with emphasis in CFC, FRS, IRIS, REGIS, DREG, RDW (Regional Data Warehouse), SMART II, GENESIS and US RRI
- Strong Process Management Experience
- Process oriented with broad technology and regulatory knowledge
- Comprehensive knowledge of Citi reporting process
- Strong interpersonal, analytical, problem solving, negotiating, influencing, facilitation, prioritization, decision making, organizational as well as conflict resolution skills
- Ability to collaborate and negotiate with global lead peers in order to deliver the expected results
- Ability to work with little direction, self-motivated
- Strong executive presentation preparation and delivery skills
- Excellent leadership, team-building and teamwork skills
- Fluency in Portuguese and/or Spanish (a plus)
- Proficiency with MS Project, blue works and MS Office Suite
- Flexibility for domestic and international travel (10% of time)
- Exposure to Citi CSS / GPO Senior Management and high pressure to achieve the expected results
- Tight deadlines
- Rapid change environment
- BS in Production Engineering, Finance or Business Administration
- Solid experience with Project Management in Finance projects i.e.: Data Warehouse, General Ledgers, ERP systems (Oracle, Peoplesoft) with a strong knowledge of the PMO discipline
- Experience working in an cross functional international business environment
13
FRC Regulatory Project Manager Resume Examples & Samples
- Driving the development and implementation of the IB business strategy
- Maintaining an independent role in the oversight of operational risks in the Investment Bank with a true front-to-back (F2B) control model
- Managing the systems and processes of multiple change and remediation programs globally
- Defining objectives, scope, approach and benefits; in particular defining how UBS should best implement the regulatory requirements in a way that creates the most commercial opportunity and/or business benefit
- Leading the implementation planning in conjunction with FRC IT
- Managing stakeholders across the Rates & Credit Sales, Trading and support functions globally
- Identifying resource requirements and associated costs in conjunction with IT
- Identifying and assessing risks
- Understanding where the project fits within the wider strategy of the FRC business and the Investment Bank as a whole
- Keeping stakeholders informed of all aspects of implementation
- Working closely with delivery partners in FRC IT and other areas of the bank
- Coordinating objectives, scope, approach and plans with other initiatives to ensure alignment
- Tracking and reporting on delivery to ensure accountability and transparency
- Removing obstacles to progress
- Resolving issues and risks as or before they arise
- Managing budgets and resourcing
- Balancing scope, schedule, quality and risk
- Overseeing the transition from the programme team into the run the bank organisation
- Monitoring benefit delivery
14
CB&S Gto-regulatory Project Manager Resume Examples & Samples
- Accountable for the successful delivery of APAC regulatory programs including project cost, scope and plan management
- Coordinate different work streams/systems to ensure that regulatory and compliance target dates are met
- Partner with the Program Director to implement and maintain the governance structure for APAC
- Creation of executive level presentations to guide steering committee meetings, provide status reports and interact with senior managers regionally and globally to provide transparency into regulatory deliveries for the region
- Reporting of progress at regular intervals to management and producing key documentation as needed
- Partner with business, compliance, operations and other functional groups to produce detailed business requirements
- Identification and, if needed, escalation of risks and issues for individual regulatory inquires or regulatory projects and programs
- Possess a degree from an accredited university in Business, Economics, Engineering or Science
- Prior work experience as a Program/Project manager or Business Analyst in a Financial Services firm; knowledge of APAC regulatory mandates or experience in a regulatory function such as compliance or audit particularly in Equities is a plus
- Adept at time management, possess ability to multi-task and prioritize work accordingly
- Well honed interpersonal, written and verbal communication skills; good interpersonal skills
- Ability to adapt to fast changing environment; Proactive, enthusiastic, detail oriented and delivery-focused
- Analytical ability to ensure comprehensiveness and detail level articulation of in analyzing and specifying of functional details
- Understanding of the Software Development Life Cycle (SDLC) with knowledge of methods and tools used to write requirements
- Ability to conduct and manage meetings facilitating requirements gathering and design reviews
- Good technical writing skills and ability to produce clear, concise and targeted documentation is a plus
15
Ihc-regulatory Project Manager Resume Examples & Samples
- Ensure the project is planned in a manner that delivers to the required cost and quality and within the agreed scope, including appropriate milestone definition, work breakdown structure, dependencies, and assumptions
- Ensure the project is resourced appropriately
- Ensure that requirements, plans, risks, issues, actions, costs, schedules, benefits, and other related project artefacts are documented and tracked
- Ensure that appropriate meetings are held and that outputs and artefacts are produced and distributed. Chair the relevant meetings
- Utilize the relevant governance bodies / steering committees for the purpose they are established
- Analyse and identify possible risks and issues that could impact delivery and either resolve them or escalate as appropriate
- Ensure the project spends according to the agreed financial plan
- Where applicable provide other relevant support as required by the programme manager
- Ensure the project closes according to required procedures
- Experienced in effectively communicating with and positively influencing project stakeholders and team members
- Appropriate domain expertise
16
Research Regulatory Project Manager Resume Examples & Samples
- Participate in ongoing training and educational activities within CCI including presenting relevant clinical research and regulatory issues. (~2%)
- Coordinates and leads other CCI activities (~2%) including
- At least 5 years of work experience in clinical research, preferably actively
- Thorough knowledge and understanding of ICH/GCP guidelines and
- Ability to analyze information and problem solve
- Maintain confidentiality of information
- Demonstrate good decision-making and judgment
- Strong attention to detail and follow-through skills
- Demonstrated organization and time management/prioritization skills with the
- Ability to effectively train and mentor
17
Human Resources Corporate Transactions & Regulatory Project Manager Resume Examples & Samples
- Coordination of key stakeholders, legal counsel, and internal strategy groups to work through the negotiation processes and legal documentation in support of the transaction. This includes scheduling meetings with key stakeholders, filling due diligence requirements, synthesizing of data and providing background information to the deal team and other stakeholders as appropriate
- Helping to ensure that HR terms are appropriately represented within the transaction documentation, in-line with Firm HR standards and approved by related governance groups (such as Tax, Accounting and Legal teams)
- Transitioning the agreed transaction terms to execution activities by production and management of work plans, status updates and coordination of regular workstream meetings for consumption by internal HR stakeholders as well as Firm/Business Unit PMO
- Driving communications throughout process from an HR perspective to stakeholders, as well as preparation and coordination of employee communication materials
- Coordinating the HR working group in support of the transaction to drive a clear and efficient execution process across all stakeholders (including internal HR, legal, tax, accounting)
- Recognizing, evaluating and acting to mitigate risk throughout the process
- Acting as HR project manager in efforts to supply information to regulators or to implement change, working closely with the Head of Risk for HR
- Drafting and/or reviewing language intended for regulatory agency consumption
- Consulting with groups across HR to understand their processes and business drivers as needed to execute the above; and by doing so, amassing a broad-based understanding of Morgan Stanley Human Resources functions
- 7-10 years of Human Resources and project management related experience
- Excellent presentation, communication and language skills with an ability to distill information to the clearest points
- Broad experience with different facets of HR with some understanding and appreciation for global HR differences (i.e. employment requirements, benefits, etc.) is a plus
- The ideal candidate will be experienced and comfortable with data management and reporting (able to define, gather and synthesize data from multiple sources to produce analysis) with demonstrated skills in excel
- Excellent analytical and conceptual skills
- Enjoys a fast-paced, dynamic environment
18
Regulatory Project Manager, Zurich Resume Examples & Samples
- University degree preferably in Business Administration, Banking & Finance or Economics and about 3-6 years front, business analysis or project management experience in the financial industry
- Interest and experience in regulatory/compliance/legal/risk management topics would be a major advantage
- Fluency in English and German; any other language skills would be an asset
19
Regulatory Project Manager Resume Examples & Samples
- Acting as a Project Manager for nominated products/projects, work effectively with global regulatory affairs personnel and with global/regional cross-functional teams to plan, prepare and deliver both simple and increasingly complex submissions which will achieve the following across a range of markets
- Knowledge of AZ Business and processes
- Appropriate regulatory experience of working in at least one areas of regulatory affairs
- Global team experience
20
Regulatory Project Manager Lead Resume Examples & Samples
- Experienced with PM tools
- PMP Certification or equivalent highly desired
- At least 5+ years working experience in Project Management leading cross-functional drug development, supply chain or regulatory teams
21
Senior Regulatory Project Manager Resume Examples & Samples
- Responsible for the delivery of IT and non-IT change within the change portfolio
- Principle liaison and coordinator between the business, IT, senior management and other members of the project including members from Head Office as and where necessary
- Active management of risks and issues, ensuring suitable escalation to the relevant parties where necessary
- Responsible for the coordination of local resources and providing updates on programme progress to senior members of the bank (e.g. local Steering Committee, ExCo, OpCo and the Hambros Board) as and where required
- Development of a plan and management of the annual budget
- Responsibility for managing, controlling, preparing and escalating risk within their scope
- Ensure timely intervention when breaches occur and analysis of root causes to avoid repeated issues
- Ensure that you take reasonable steps to be fully aware of, understand and comply with all regulatory requirements from all regulatory bodies that are applicable to your business
- Perform all duties in accordance with the principles outlined in the SGPBH Code of Conduct, as well as the policies and procedures relevant to your responsibilities, to ensure that you adhere to a culture that treats clients fairly and focuses on the long term sustainability of client relationships
22
Regulatory Project Manager Resume Examples & Samples
- Co-ordinating and managing multi-disciplinary projects for pesticides to support authorisation of active substances and products at EU and Member State level
- Providing strategic regulatory advice to clients and colleagues alike for plant protection products in the EU
- Ensuring that projects are delivered to high standards, on time and within agreed budget
- Assisting in the development of new business with existing and new clients for the provision of regulatory service
- BSc. in chemistry, pharmacology, biology or a closely related field together with experience of working in a regulatory environment
- Proven track record of working in regulatory affairs for plant protection products at EU and Member State level
- Excellent communication skills including the ability to explain complex regulatory issues to different types of audience
- Business development experience is a plus
- Ability to work independently and manage multiple assignments under rigid time constraints
- Ability to collaborate with diverse colleagues and participate effectively in team projects is essential
23
Regulatory Project Manager Resume Examples & Samples
- RA delegate within project teams and assuring execution of optimal regional/local affiliates regulatory submission strategies
- Strategic and operational regulatory support to affiliates in the defined area
- Close collaboration with stakeholders globally, in the region and in-country including regulatory affairs, R&D, portfolio, supply chain and commercial
- Manages, coordinates and consolidates files suitability & feasibility for portfolio's wish lists and files due-diligence reports; gaps analysis and mitigation plans for strategy PRC in alignment with COREX centers teams
- Discuss with R&D projects in development prior to project allocation, ensuring that the regulatory activities are set and are in line with market requirements; i.e. attendance and active participation in selection meetings, introduce RA strategy input in PLM, and provision of FSD and submission timelines
- Proactive Project management of submissions execution according to submissions WP, tracking progress and interact with the regulatory staff affiliates as needed. Provide support to local affiliates by opening bottle necks to ensure on-time submission and launches
- Takes responsibility from strategy definition until launch and act as the RA delegate for regional functions forums including R&D and Portfolio
- Have an overview of the entire projects registration status for a defined area – pre & post approval/commercial
- Internally works in interface with RA officers in the RA centers and with regional maintenance & compliance manager
- Minimum 6 years’ experience in Regulatory Affairs or R&D, preferably with experience in a similar role
- Degree in life sciences/ pharmacy or equivalent qualification(s)/experience
- Excellent team-work and communication skills
- Drive for results and excellence
- Proven project management skills and attention to detail
- Good knowledge of the industry
- Confidence and communication skills are important for managing relationships both internally and externally
- Proficiency with spoken and written English and Spanish
- Travel Requirements – Less than 25%
24
CMC Regulatory Project Manager Resume Examples & Samples
- Bachelor degree in pharmacy, chemistry or related scientific discipline or equivalent qualification
- Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience gained with direct involvement in regulatory submission preparation across all stages of development through to early life cycle submissions
- Knowledge of worldwide CMC regulatory requirements and successful track record of delivering dossiers that comply these, particularly for new medicines in development
- Proven ability to develop and implement regulatory strategies and evaluate the potential impact of them on overall project/product strategy
- Excellent team working abilities and effective influencing skills
- Strong verbal and written communication skills with good attention to detail
- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
- Ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
- Experience of CMC regulatory submissions for oligonucleotide products
- Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities
- Strategy development and creation of CMC submission documents from early phase clinical submissions through to marketing applications and early lifecycle activities
- Understand, interpret and advise on regulations, guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, to expedite submission, review and approval of global CMC applications
- Work in cross-functional matrix project teams, which include colleagues from regulatory, chemical and pharmaceutical development and manufacturing
- Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment
25
Regional Regulatory Project Manager Resume Examples & Samples
- Provide input into Area & Affiliate regulatory strategies & deliverables for compounds at all stages of development
- Maintain an awareness of EU regional requirements in the overarching global regulatory strategy; develop risk assessments and make sure they are taken into account at the Global Regulatory Project Team level
- Represent the Area/Affiliate regulatory requirements and interests (RA affiliates and commercial) on assigned teams
- Interface with Commercial including representing Regulatory on the Brand Teams to provide strategic input at all levels of the product lifecycle
- Support local Health Authority interaction in conjunction with area/affiliate teams
- May be responsible for direct liaison with EMA for products within the Therapeutic area
- Degree level education or equivalent - in a life sciences discipline
- Previous proven experience in pharmaceutical Regulatory Affairs
- Some above country / regional experience - ideally in the major EU countries
- Recent experience of Centralised Procedures
- Experience of working directly with the EMA / other external agencies preferred
- Recent experience of working with products in the earlier phases of development preferred Experience working effectively across cultures and in a complex matrix environment
- Proven experience of working effectively with commercial parts of the organisation Strong leadership presence and solution driven style
- Demonstrated success in negotiating skills
- Strong interpersonal, and organisational skills
- Confidently build relationships with stakeholders across regulatory affairs and functions of the business
- Assess impacts on regulatory strategy and the business based on sound awareness of EU legislation
- Anticipate regulatory risks and proactively develop potential solutions
- Take the initiative, eager to learn and to deliver results
- Are a good communicator, are tenacious and highly determined
- Build relationships widely, make high quality decisions, are patient focused
- Manage concepts through to reality, anticipate the future and seize opportunities
26
Regulatory Project Manager Resume Examples & Samples
- Working alongside senior management and project teams across the business, S/he offers process, tool, and life cycle guidance on regulatory changes and assessments, along with action plans as appropriate, ensuring that regulatory change management is well planned
- S/he will help the business management to track performance to plan and monitors key process/project deliverables
- S/he advocates, supports and has experience in the implementation and utilisation of project management tools
- S/he will provide project metrics including RAG status, milestone tracking, dependencies, issue tracking
- S/he will lead regulatory specific Sub-Committees for Markets where regulations require it for example on Client Asset Safeguarding
- S/he uses experience to provide insight to planning processes and provide mentoring to project staff across the organisation
- Detailed knowledge of the Markets organisation and products would be useful
- Industry knowledge of the business structure as a whole will be necessary to enable this person to understand delivery of functional specifications and design based on the business requirements and strategy
- A good working knowledge of Client Asset Safeguarding Requirements collateral management processes and/or the securities lending business especially will be important
- Previous experience of understanding and advising how a business line can fit its working practices to the functional requirements of any relevant regulations, as well as communicating this in a practical manner to senior management in order to meet project goals and aims
- Proven ability and experience in thinking laterally in applying regulatory changes across the groups
- Demonstrate the understanding and confidence to actively work with the Markets groups and their senior management to help them understand how regulatory change affects them, and what they must do in order to implement the regulation within their business
- An understanding of the Compliance environment will be an advantage
- They must help the management team understand how regulatory projects will affect their business, as well as help them to understand the practical application of change across their business groups
- They will need strong negotiation skills and be a clear and precise thinker
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CMC Regulatory Project Manager Resume Examples & Samples
- Directly manage completion of multiple dossier components to meet project timelines
- Review documents and dossier components to assure that technical/regulatory strategy and data integrity processes are followed
- Accountable for ensuring that dossier components meet global/regional standards for content, quality, and regulatory requirements
- Work closely with project team members and CMC regulatory team to produce high quality submissions
- Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes. Effectively adjust plans to deal with changes and obstacles
- Identify, document, and communicate regulatory project risks that could impact timeline and quality of regulatory submissions
- Organize and archive CMC dossier components and supporting documents in appropriate document management systems
- Interface with regulatory operations staff to coordinate dossier review, approval and publishing activities
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Regulatory Project Manager Resume Examples & Samples
- Provide project management, prioritization, direction and leadership to team members in order to accomplish defined project deliverables
- Develop project scope, budgets, project plans and communication plans
- Align functional expertise and solutions to meet the changing demands of clients, competitors and regulators
- Manage regulatory and compliance projects
- Create and manage project work plans, issues, risks, and key decisions
- Leverage EPMO best practices and complete project artifacts
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Senior Regulatory Project Manager Resume Examples & Samples
- Identify, develop, and resolve SCE operational and regulatory policies and strategies to be reflected in the various DR-related proceedings
- Plan, prioritize, staff, schedule, and other project management activities
- Development of regulatory documents such as Applications, Advice Letters, Direct and Rebuttal Testimony, and Comments
- Management of timely responses to discovery requests from CPUC Staff, other regulatory agencies, and other stakeholders
- Communication regarding status of customer service related proceedings to SCE executives and internal and external stakeholders
- Preparation of witnesses and support for evidentiary hearings
- Analysis and communication of regulatory proposed and final decisions and resolutions
- Represents SCE with regulatory agencies, customer advocacy groups, other utilities, various governmental bodies, community/civic groups, etc
- Provides input and recommendations on issues in other regulatory proceedings with impacts on, or affected by, DR
- Collaborates with Regulatory Affairs colleagues to achieve consistency on positions across regulatory proceedings
- Support other Customer Service related regulatory proceedings as needed
- Bachelor’s Degree in Business, Public Policy, Public Administration, Economics, or related field
- Must have seven or more years’ experience in project management or similar cross-functional coordination, and/or strategic planning, and/or energy markets, and/or regulatory policy
- Must have experience analyzing and interpreting regulations, legislation or policies
- Experience developing regulatory documents such as Applications, Advice Letters, Direct and Rebuttal Testimony, and Comments
- Experience leading cross functional project teams
- Typically possesses seven or more years of experience in regulatory affairs, operational programs, contact management, or function being managed plus seven or more years of supervisory or project management experience
- Electric utility industry experience
- Demonstrated knowledge of state and federal regulatory and/or legislative functions and processes
- Demonstrated experience developing and delivering presentations to stakeholders and senior management
- Customer focused to understand and respond appropriately to clients' business needs
- Demonstrated ability to take initiative, be accountable for individual results, and motivate self and others to set and achieve high performance standards
- Demonstrate strong organizational skills with high level of initiative and ability to effectively interface, collaborate, and partner with stakeholders, senior management, clients and team members to help drive solutions and ensure stakeholder buy-in
- Proficient with Microsoft Word, Excel, PowerPoint, Project, and Visio
- Ability to follow Edison safety protocols and safe work practices
- Must demonstrate effective decision making, results delivery, team building, and the ability to stay current with relevant technology and innovation
- Must demonstrate strong ethics, interpersonal skills, and the ability to effectively manage stress and engage in continuous learning
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Regulatory Project Manager Resume Examples & Samples
- In depth understanding and practical experience of national or/and EU regulations, guidelines and working practices and of the regulatory issues relevant to the portfolio
- Knowledge of drug development process and regulatory affairs
- Knowledge of the commercial and medical issues pertaining to the assigned portfolio, including an awareness of competitor products and activities
- Ability to work in a complex environment
- Good interpersonal and influencing skills
- Has an understanding of the impact of the regulatory environment and proposed changes which are likely to impact the business in the medium term
- Can define regulatory strategy
- Has an indepth understanding of regulatory governance, medical and safety
- Ensure product information is compliant with MA. Ensures that GSK product Summary of Product Characteristics (SPCs) and Patient Information Leaflets (PILs)/ labeling are compliant with MA and with regulatory requirements
- Ensures that the current SPC and PILs are available to Healthcare Professionals on electronic compendia in UK and Ireland
- Co-ordinates national input into responses to regulatory questions and regulatory commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines
- Responsible for the local management of product registration documents in regulatory databases and repositories
- Manage regulatory agency correspondence in accordance with company procedures
- Completes Marketing Authorisation Holder (MAH) review of Periodic Quality Reviews for all registered products in responsible portfolio for which GSK Ireland is MAH
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Regulatory Project Manager Resume Examples & Samples
- Bachelor degree or preferably PhD in biological or healthcare science
- Knowledge of the drug development process
- Knowledge of regulatory agency guidelines and expectations for submissions and ability to interpret as required
- Knowledge of regulatory agency review processes globally for both marketing applications and clinical trial applications
- Ability to interpret and advise on guidelines and requirements on a global basis
- Ability to build effective working relationships
- Primary responsibility is for leadership of, preparation and review of day to day submissions with full accountability for delivery
- Accountability for larger submissions as part of an overall project plan i.e. line extensions, major components of a submission of a NCE, major responses etc
- Developing components of regulatory strategy for a region
- Ensuring quality of both own and submission team work and compliance with regulatory guidelines and process within the required timelines
- Lliaising with Regulatory Agencies to resolve straight forward issues in relation to their accountabilities
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Regulatory Project Manager Resume Examples & Samples
- Business Travel or Temporary Duty (TDY) may be required 10-35% but may be as much as 50%
- Ability to prepare environmental documentation
- Ability to participate in the enforcement process
- Ability to communicate
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Regulatory Project Manager Interdisciplinary Resume Examples & Samples
- Temporary Duty Travel is 10% to 20%
- Knowledge in the Areas of Biology and Environmental Protection
- Knowledge of the Permit Process
- Ability to Communicate Effectively
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Program Analyst / Regulatory Project Manager Resume Examples & Samples
- Bachelor's Degree in Political Science, Economics, Health Care Policy or related area
- Minimum of Five (5) years experience in at least one subject area: healthcare data/payor analysis, health care policy analysis, economics, legislative/congressional experience
- Strong understanding of the health care industry, including health care reform and trends, quality and performance management, inpatient and outpatient operations, finance, etc
- Excellent collaboration, interpersonal, meeting facilitation, presentation, written, listening, and verbal communication skills
- Strong interpersonal skills and ability to work with internal and external stakeholders including other analysts, clinicians, and federal/state/payer program representatives
- Demonstrated ability to analyze information and present in an understandable fashion to groups
- Demonstrated ability to work independently and with a high degree of creativity
- Excellent analytical and problem-solving ability
- Flexibility to adapt to a changing environment
- Master's Degree in related field such as economics, political science, health care policy, public health or community health care preferred
- Experience in an analytical and policy environment
- Experience with reporting and analytic tools (e.g., SAS, Excel, Tableau, MS Access)
- Understanding of Healthcare quality measurement and improvement
- Experience with Process Improvement methods such as PDCA, Lean, etc
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Regulatory Project Manager Resume Examples & Samples
- BSc in life sciences or equivalent qualification
- Practical experience with cell therapy, gene therapy or biopharmaceutical medicinal product development gained from a Regulatory Affairs or technical role
- Experience of authoring or preparing CMC content for clinical trial applications and/or marketing applications
- Capable of working effectively with technical experts and making decisions independently
- Successful track record of delivering CMC strategies and submissions content that comply with global regulatory requirements
- Working closely with technical experts in cell and gene therapy/biopharmaceuticals and colleagues in other regulatory functions
- Representing CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams and the global manufacturing organisation
- Responsibility for global CMC regulatory activities for projects teams, setting the strategy for CMC regulatory content of clinical trial applications and marketing applications
- Understanding, interpreting and advising on regulations, guidelines, procedures and policies relating to development, registration and manufacture of cell and gene therapy products/biopharmaceuticals
- Change control requests, and post-approval submissions, ensuring delivery to agreed timelines
- Maintaining high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment
- Communication across the company to influence CMC project and policy issues that are aligned with business needs
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Risk Regulatory Project Manager Resume Examples & Samples
- Communication with the local regulators in the areas related to risk management
- Management of all regulatory risk related requests and projects
- Coordination of the projects related to LLP procedures
- Development and preparation of reports to Management Committee and Supervisory board on the local risk management in Ukraine
- Development and maintenance of the data base of the risk related laws and regulations
- Development of local risk related procedures
- Timely update local risk management procedures, incl. loan loss provision procedures, lead the process of the implementation of the new procedures
- Represent Risk during local regulatory audits
- As a matrix supervisor, oversee the LLP process to ensure compliance with the regulations and high quality of the reports/submissions
- Good knowledge of banking practices and global functions, as well as related legal and regulatory requirements
- Strong knowledge of accounting
- Comprehensive knowledge of audit/risk assessment techniques and principles
- Master degree in Banking/ Finance/ Legal/Economics/Mathematics (or equivalent)
- Fluent in Ukrainian and Russian, good command of English
- Adequate knowledge of Microsoft Office
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Human Resources Bank Regulatory Project Manager Resume Examples & Samples
- Representing Human Resources in company-wide committees and working groups tasked with key initiatives required by the Firm’s regulatory agencies across the globe
- Acting as HR project manager in efforts to supply information to regulators or to implement change, working closely with HR partners involved in regulatory inquiries to gather data and compile information relevant to requests
- Understanding HR’s role in the context of Firm-wide risk and strategic initiatives, and collaborating with counterparts in other business units
- Driving communications within HR as appropriate
- Tracking and maintaining an activities log for all Regulatory related deliverables
- Coordinating materials and assisting the HR team in regulatory and internal audit exams
- Developing relationships with counterparts across multiple lines of business and support areas, in order to collaboratively deliver on cross-functional projects. Serve as the front face of the Human Resources division in such contexts
- 7-10 years of Human Resources and/or project management related experience ideally in an Audit, Compliance or Risk related function
- Personable, with ability to finesse a situation and build consensus among stakeholders, strong team player
- Strong understanding of operational risk concepts, and an appreciation of the need for and complexity of implementing change and controls to mitigate risk as appropriate to a business
- Experience interacting with divisional management-level stakeholders; ability to collaborate with or pitch a message to audiences at various levels of the organization
- Background from a compensation and benefits perspective is a plus
- Experience with data management and reporting (able to define, gather and synthesize data from multiple sources to produce analysis) with demonstrated skills in excel
- Ability to manage multiple priorities simultaneously
- Role is based in Purchase with frequent travel to midtown Manhattan office
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Senior Regulatory Project Manager Resume Examples & Samples
- Identify, develop, and resolve SCE operational and regulatory policies and strategies to be reflected in the various EE-related proceedings
- Communication regarding status of EE-related proceedings to SCE executives and internal and external stakeholders
- Represents SCE with regulatory agencies, customer advocacy groups, other utilities, various governmental bodies, community / civic groups, etc
- Provides input and recommendations on issues in other regulatory proceedings with impacts on, or affected by, EE
- Six years’ experience in project management or leading teams and/or strategic planning, and/or regulatory policy
- Experience analyzing and interpreting regulations, legislation or policies. Demonstrated oral and written communication experience within the above
- Master’s in Public Policy/Economics/MBA or other relevant graduate degree or Law degree
- Two years of experience with CPUC regulatory issues / processes; basic knowledge of utility finance and ratemaking principles
- Five years of experience in regulatory affairs, operational programs, contract management, plus five or more years of supervisory or project management experience
- Knowledge of state and federal regulatory and/or legislative functions and processes
- Experience developing and delivering presentations to stakeholders and senior management
- Customer-focused to understand and respond appropriately to clients' business needs
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CMC Regulatory Project Manager Resume Examples & Samples
- Bachelor’s degree in life sciences or related scientific discipline
- Sound knowledge of worldwide CMC regulatory requirements for biopharmaceutical products
- Detailed knowledge of biopharmaceutical drug development and manufacturing/supply processes
- Minimum of 5 years’ experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related activities and functions
- Experience in CMC regulatory affairs is preferable
- Experience with biopharmaceutical products (e.g., monoclonal antibodies and therapeutic proteins) is preferable
- Ability to manage and lead multiple projects/teams simultaneously
- Global CMC Regulatory experience with biopharmaceuticals (e.g., monoclonal antibodies and therapeutic proteins)
- Continued professional growth in global regulatory affairs, including communication of evolving trends and policies
- Broad knowledge base of regulatory functions to understand wider implications of emerging issues across projects
- Experience in influencing and negotiating with technical personnel in a variety of settings
- Strong technical writing skills and attention to detail
- Strong verbal communications skills and demonstrated ability to work in a matrix/team environment
- Ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
- Strong computer skills in Microsoft Office applications with the ability to learn new applications quickly and easily
- Experience with preparation of CMC submissions (INDs, IMPDs, amendments, BLA/MAA, supplements, variations) is preferable
- Expert knowledge and hands-on experience in at least one area related to CMC Biopharm product development (e.g. analytical or process development, manufacturing, quality control)
- Provide guidance to functional area authors/reviewers with regards to clinical and marketing submission and dossier requirements. Understand, interpret, and advise on regulations, guidelines, procedures, and policies relating to the development, manufacture, and successful global registration of biopharmaceutical products
- Work closely with project management and CMC regulatory team to execute plans for managing workload within assigned project objectives through efficient resource utilization and within designated timeframes
- Effectively adjust plans to deal with changes and obstacles
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Client Data Services Regulatory Project Manager Resume Examples & Samples
- Review and understand new requirements and identify impact to global Client Onboarding. Vet changes with Legal, Compliance, Business Management, etc globally to ensure changes meet both regulatory needs and business requirements
- Work with IT to define any system changes, put together BRD documents, and perform UAT as necessary
- Develop "Future State Process Flows" and associated Key Operating Procedures incorporating new regulatory changes
- Coordinate changes with other Client & Data Services Regulatory teams to ensure solutions are consistent
- Review changes with internal Client Onboarding Run-The-Bank teams and obtain sign off
- Train onshore, nearshore and offshore teams on new procedures
- Serve as regional SME on regulations and support RTB teams with questions and escalations
- Review and QA sample of RTB cases to ensure regulations are being implemented correctly
- Management of daily control reports which includes working with offshore team to investigate and analyze the exceptions, identify remediation steps, and follow-up with internal or external stakeholders until exceptions are resolved
- Work with various Audit teams to pull data and explain process during internal and external review process
- Associate's or Bachelor's Degree
- Applicants for this position should ideally have experience working with and implementing regulations within an Operational or Control department within a banking environment, or within a similar Operations regulatory function
- Understanding of the workings of an investment bank and the lifecycle of a trade is a plus
- Knowledge of Client Onboarding and Regulators is a plus
- Must be able to work both independently and as a team player
- Must be determined and hardworking, ability to work under pressure and within tight deadlines with no loss of accuracy
- Pays attention to detail and can multi-task
- Presentable and articulate with strong written and oral communication skills to deal with front office, back office trade capture teams, control areas, IT and clients
- Shows initiative and reacts quickly to changes in priorities
- Possessing strong organizational skills
- Confident, determined with a lively and open personality
- Ability to learn new practices and procedures quickly
- Commitment to seeing quality results from his/her own endeavors
- Competent business user of MS products and Outlook. Internet literate to enable on-line searches. Must know MS Excel. Knowledge of Markit ISDA Amend is a plus
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Regulatory Project Manager Resume Examples & Samples
- Medical writing
- Controlled substances (e.g. DEA)
- Country specific regulatory support
- Regulatory history, guidelines, policies, standards, practices, requirements and precedents
- Ethical guidelines of the regulatory profession, clinical research and regulatory process
- Communicate effectively verbally and in writing
- Organize and track complex information
- Exercises good and ethical judgment within policy and regulations
- Uses in-depth knowledge of business functions and cross group dependencies/ relationships
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Regulatory Project Manager Resume Examples & Samples
- Assist in coordinating the analysis and implementation of significant compliance projects affecting CGM businesses and various internal projects
- Assist with/ lead the analysis of the regulatory requirement/s and how it/they impact/s the relative business/es
- Participate in business impact assessments and discussions with Legal, Compliance, Operations, Business Operational Risk Manager and the affected businesses
- Assist senior management, the relevant businesses and support functions with the design of frameworks to ensure compliance with the new requirements
- Assist with/lead the development of compliance policies, processes and other responses (e.g. governance, monitoring and surveillance requirements)
- Identify structural solutions including deployment of resources
- Develop and contribute to senior CGM management reporting regarding these projects
- Develop and contribute to training programmes regarding these projects
- Maintain relevant IT regulatory system/s
- Manage change requests and priority changes in dynamic business-lead environment
- Prepare and deliver effective project presentations as required
- Comprehensive understanding of Global regulation, with emphasis on FCA and PRA (European) current and proposed rules governing Global institutions
- Experience with building/assessing governance and compliance frameworks in response to new regulations and standards
- Proven effective communication skills with stakeholder sets that include the global business, Operations, Legal teams and Compliance to deliver timely solutions
- Strong project management and team working skills, with proven results implementing regulatory change within a commodity based environment. The role will encompass the end to end delivery and involve working with both onshore and offshore delivery teams as well as multiple stakeholders across the CGM businesses
- Experience with Board and senior management reporting
- Cross-border experience with different Global regulatory regimes preferred
- Excellent Microsoft Project and Microsoft Office (Word, Excel, PowerPoint) skills
- Broad understanding of front, middle, and back office functions
- Good understanding of trading systems
- Outstanding academic results in a relevant discipline such as Finance, Economics, Accounting or Law or relevant regulatory project management experience
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Regulatory Project Manager Resume Examples & Samples
- Gather requirements from a wide-array of stakeholders (FO, Legal, Compliance, Operations, IT, etc)
- Participate to industry working group (ISDA, ASIFMA…)
- Conduct a gap analysis and impact analysis
- Drive the design of business solutions and/or contribute to the development of requirements
- Write Business Requirements Documents and test cases
- Follow-up on development plans and implementation, participate in solving issues and escalate issues and blocking points
- Perform UATs and organize/conduct UAT sessions with stakeholders
- Be able to manage the project reporting with the help of the program manager
- Enhance and maintain transversal artifacts created as part of the documentation base for the Program; and
- Develop and extend knowledge of the regulatory rules and associated solutions
- Knowledge of/experience with OTC Derivatives products
- Knowledge of OTC Regulation especially on Clearing and Margining
- Knowledge of/experience with Trading Lifecycle Event / Clearing / Collateral Management
- Knowledge of/experience in Project Management
- Understanding of Software Development lifecycles
- Use of Microsoft Office tools with ease, including Visio
- Ability to assimilate, analyze and communicate a wide variety of information
- Ability to break down a problem into constituent parts
- Ability to work collaboratively in a team environment with people on site as well as people in remote locations (APAC, Paris, London, India)
- Analytical and Problem solving skills Extremely organized, disciplined person and has the ability to work to strict timescales
- Ability to manage multiple simultaneous work-streams, dealing with multiple stakeholders and managing across numerous initiatives as well as ensure timely and robust delivery
- Good communicator and attention to the detail
- Degree in Finance, Information Systems, Technology or other related field
- Significant regulatory transformation experience
- Banking/Investment/Financial services experience
- Experience working as PM for a Top Tier Investment Bank
- Experience in any of the following fields: clearing, collateral, risk management, OTC derivative products
- Strong delivery record – to challenging time-scales
- Proven ability to lead teams and leverage this for maximum efficiency
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Regulatory Project Manager Interdisciplinary Resume Examples & Samples
- 25% or Greater
- Temporary duty away from the office is at occasional up to 25% to conduct field work,or attend training/meetings
- Knowledge of Water Resource Permitting Procedures
- Skill with Project Management
- Ability to Monitor/Implement Regulatory Enforcement
- Skill with Communication
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Regulatory Project Manager Resume Examples & Samples
- Responsible for all regulatory submissions and reports for products manufactured at La Jolla site; Includes PMA supplements related to CMC changes and periodic reports for cellular combination products
- Researches regulatory and scientific information to develop regulatory strategies; Writes and prepares submissions to FDA (CBER)
- Independently manages and coordinates resources for all phases of submission preparation, communication with internal/external customers, and facilitating approvals
- Interacts with government agencies, regulatory bodies and officials, as necessary, to facilitate product approvals, maintain compliance and communicate pertinent information
- Responsible for providing regulatory input and recommendations to identify appropriate pathways and develop strategies for approval and commercialization of products in international markets
- Works with internal and external partners to plan and execute activities necessary to facilitate global regulatory approvals, including dossier submissions
- Lead and participate in cross-functional teams and projects related to product development, manufacturing, and commercialization
- Provides review and regulatory input for development plans, testing strategies and technical/quality documentation
- Develop, write and review Standard Operating Procedures (SOPs) and protocols
- Collaborate with Quality Assurance to manage programs and ensure regulatory compliance with product development, validation, and commercialization activities subject to regulations established by US, EMEA, and other worldwide governments (as required)
- Strategically manages competing priorities, provides leadership and coordinates cross-functional resources that have a direct impact on site operations and opportunities. When appropriate, provide strategic guidance for problems being discussed and recommend solutions
- Identifies and communicates new and relevant changes to applicable regulations, guidance, standards, other applicable regulatory policies to provide insight to the Regulatory Department and cross-functional teams and ensure compliance with new requirements and current best-practices
- Interact with outside consulting groups and manage activities necessary for completing key initiatives. Provide mentoring to current staff and have skill sets for directly managing staff
46
Regulatory Project Manager Resume Examples & Samples
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions
- Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including
- Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
- General knowledge of drug development
- Regulatory experience
- Managed regulatory deliverables at the project level
- Thorough knowledge of the drug development process
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project) and document management tools
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused
