Regulatory Project Manager Job Description
Regulatory project manager
provides regulatory support for new drug development projects in close alignment with CMC Managers in various therapeutic areas.
Regulatory Project Manager Duties & Responsibilities
To write an effective regulatory project manager job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory project manager job description templates that you can modify and use.
Sample responsibilities for this position include:
As assigned, lead projects of varying scope and size through entire project lifecycle
Experience developing project charters, project plans (Microsoft Project), status reports and risk/issues logs and maintaining project artifacts in SharePoint
Analyse current process and workflows to understand how this change will affect each stage
Facilitate communications between Front Office, Compliance, Operations and Technology on every stage of the projects
Integrates project plans creating estimating models as required, refines plan and manages performance against it
Facilitates schedule and cost forecasting and determining risk based provisions
Champions strong IT governance through the creation of a project decision framework
Represent the bank in participating industrial forums
Develop and ensure timely delivery of regulatory messages via email, intranet, presentations, talking points, newsletters, articles, Q&A sessions, town halls
Partner with relevant stakeholders to analyze and document business requirements and operating model
Regulatory Project Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Project Manager
List any licenses or certifications required by the position: PMP, RAC, II, PRINCE, PMI, CE, NRTL, CPMA, MBA, CPA
Education for Regulatory Project Manager
Typically a job would require a certain level of education.
Employers hiring for the regulatory project manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Engineering, Chemistry, Science, Medical, Education, Biology, Pharmacy, Health Sciences, Department of Education, Biological Sciences
Skills for Regulatory Project Manager
Desired skills for regulatory project manager include:
Drug development process
Drug development
AZ Business and processes
Particularly for new medicines in development
Process and project planning best practices
New and developing regulatory and pharmacovigilance expectations
Drug development and manufacturing and supply processes
Biopharmaceutical drug development and manufacturing/supply processes
Regulatory agency guidelines and expectations for submissions and ability to interpret as
Worldwide CMC regulatory requirements
Desired experience for regulatory project manager includes:
Knowledge on OTC trade reporting requirements/processes are highly desirable
Experience in delivering similar regulatory projects (Dodd-Frank Act, EMIR)
Good capability with MS Office tools
Excellent relationship management skill, demonstrated by the engage, influence and manages different groups of stakeholders across all levels
Develop and implement tax related services
Conceive and develop innovative solutions to address complex regulatory requirements and extend the tax related service offering
Regulatory Project Manager Examples
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Regulatory Project Manager Job Description
Job Description Example
Our company is looking to fill the role of regulatory project manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory project manager
- A bachelors degree or the equivalent work experience or qualifications
- High levels of initiative, with a proven ability to work independently with minimum supervision
- Able to use your initiative
- Problem solving orientated and action driven
- Analytical and structured in your thinking
- Organised and able to handle large volumes of work in an efficient and timely manner
- Willing to develop your regulatory knowledge
- Willing to adapt, commit to deliverables and listen
- Support process governance for the development of Global expertise in relevant liquidity legislation and requirements
- Support Finance Liquidity interpretation team’s prioritisation and task management
Qualifications for regulatory project manager
- Establishing a framework where risks and issues are reviewed on an on-going basis
- Oversight of IT regulatory compliance with policies, standards, guidelines, processes, and procedures
- Proven track record of developing corporate governance and risk management frameworks and solutions from inception
- Experience in implementing internal control assessment processes and tools used to facilitate compliance with Section 404 of the U.S. Sarbanes-Oxley Act (“SOX 404”) Financial Industry Regulatory Authority rules
- Experience in designing and implementing programs incorporating diverse products and services in varied regulatory environments and geographies
- Ability to implement rigorous process and program management governance and transparency
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Regulatory Project Manager Job Description
Job Description Example
Our company is looking to fill the role of regulatory project manager. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory project manager
- Co-ordinating and on occasion managing the implementation of Corporate and Regional regulatory projects (such as the adoption of new regulations) that have a dependency on the Frankfurt legal entities and in particular on Client Service Delivery
- Taking responsibility for ensuring that the Frankfurt legal entities and their management are at all times complaint with relevant regulation, that they have the correct regulatory controls and policies in place and that the necessary skills, knowledge and practices are present to enable the business to be compliant
- Acting as the first point of escalation both from within the business and from Risk, Compliance & Internal Audit where regulatory matters are involved impacting the Frankfurt location
- Making sure that a robust control environment is maintained while executing on change and transformation activities in Frankfurt
- Acting as the Frankfurt lead on Client Asset Protection (CAP) remediation and ensure the ongoing CAP operating model in Frankfurt
- As a first line manager, focusing on the risk and control issues of the Frankfurt legal entities ensuring that all relevant operational issues and risks are captured and escalated, where appropriate
- Reviewing and consulting on the implementation of regulatory policies and procedures
- 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 Firm/Business Unit PMO
- Driving communications throughout process from an HR perspective to stakeholders, preparation and coordination of employee communication materials
- Provide change management leadership and guidance to ensure sustainable transformation
Qualifications for regulatory project manager
- An innovative, analytical thinker with track record in influencing senior decision makers, with an ability to drive adoption across both IT and the business
- Excellent education credentials a plus
- Work with the Program Manager and Sponsors to co- ordinate scope, resource and communications with assigned portfolio of projects
- Develop project plans based on analysis of regulations conducted by Subject Matter Experts and Business Analysts
- Organise and control the activities of cross functional work streams and stakeholders in multiple global locations within each project
- Track and manage project budget and commercial implications
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Regulatory Project Manager Job Description
Job Description Example
Our company is looking for a regulatory project manager. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for regulatory project manager
- Support execution of regulatory strategy under leadership of the Global Regulatory Lead
- Responsible and accountable for planning, managing, tracking and on-time production of regulatory deliverables for major global submissions
- Coordinate Regulatory Sub Team (RST) as project manager
- Accountable for the leadership and day-to-day operation of the Dossier Task Force, including maintaining compliance with dossier compilation and global submission processes
- Communicate process, timelines, and document standards to authors
- Ensure all dossier components receive content review by relevant GRA leadership
- Maintain the regulatory information management database
- Network with GPT and sub team members to understand risks to the successful delivery of submissions
- Point of contact regarding time lines and status of submissions / approvals globally
- Coach more junior regulatory project managers and actively participate to the development of competences within the RA project manager community
Qualifications for regulatory project manager
- Reporting qualitative status of programs addressing a regulatory requirement
- Sufficient credibility to influence project teams and senior management in relation to these functions
- Understand, follow and demonstrate compliance with all relevant internal policies and procedures and provide input to the further development of best practices
- Knowledge of operational processes in financial services required - regulatory knowledge ideal
- PRINCE 2 qualification preferred
- Established track record of delivery in a complex and fast paced environment
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Regulatory Project Manager Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory project manager. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for regulatory project manager
- Interpret impacts of new regulatory requirements on existing market risk processes
- Report on status and monitor the day to day execution of the programme using both local and Head Office reporting tools including PRIME
- Ensures that project documents are complete, current and appropriately communicated to stakeholders
- Maintain an awareness of EU regional requirements in the overarching global regulatory strategy
- Accountability for larger submissions as part of an overall project plan line extensions, major components of a submission of a NCE, major responses
- Performs and directs performance of Section 404 wetland delineation – both simple vegetation examinations and full three-parameter testing – in accordance with U.S. Army Corps of Engineers (USACE) regulations and the USACE Wetland Delineation Manual
- Determines jurisdictional limits of various laws and regulations including Section 404 and 401 of the Clean Water Act
- Educates client in permit processes
- Develops scopes of work for regulatory related projects, calculates project budgets and fees, and develops project schedules
- Writes and supervises writing of environmental assessments and environmental impact statements in accordance with the National Environmental Policy Act and USACE regulations
Qualifications for regulatory project manager
- Budgeting and cost management of actual vs
- Management of Managed Expenditure Requests (MER) for consultant on-boarding including invoice tracking for actuals vs
- Developing and tracking project plans, forecasting and tracking budget
- A Business Analyst Background preferable
- Front Office Exposure desired
- Relevant Investment Banking experience, preferably within Regulatory Compliance
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Regulatory Project Manager Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory project manager. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory project manager
- Assesses and directs assessment of impacts related to project implementation and manages project team in development of appropriate mitigation in accordance with agency regulations and policy, and in accordance with client objectives, including development of Conceptual Mitigation Plan
- Coordinates consideration of endangered species issues with FWS and writes, or manages writing of biological assessments used to initiate formal consultation between USACE and FWS in accordance with Section 7 of the Endangered Species Act
- Prepares 404(b)(1) evaluations (including alternatives analyses) in accordance with EPA regulations and USACE policy
- Develops and implements Conceptual Mitigation Plans and monitoring requirements
- Manage the larger and more complex projects for large Life Science clients, specialising in Regulatory work
- Communicate well with senior level client contacts, local offices, freelancers and internal project team members
- Develop processes and methodology to ensure project success and value added service to clients
- Ensure accurate compilation and approval of estimates and proposals for existing clients and potential new customers by complying to the LQI sales process
- Plan projects through risk assessment planning, best process identification, implementation of best methodology and communication to project teams
- Closely monitor projects by the comprehensive and effective use of standardised server project folder structure and thorough filling of project assets and documentation, budgets, change orders, resource request forms, handover documents, MDS, Status.xls, status sheets, timely invoicing and payment tracking
Qualifications for regulatory project manager
- Knowledge of Risk reporting practices and/or Financial Services Regulatory Reporting practices preferred
- Strong communication skills, both verbal and written, with particular emphasis on the production of clear and detailed written Business Requirements and Functional Specifications
- Ability to work independently (self-motivated) and with a distributed team (i.e., physically located in other regions)
- Strong SQL and data management experience
- Understand and analyze business processes & workflows
- Excellent knowledge of regulatory environment of Financial Services in Germany and across EMEA