Regulatory Program Manager Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Program Manager Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

The Regulatory Program Manager (RPM) functions as a regulatory operations leader driving projects forward through the translation of regulatory strategy to executable plans and coordination of cross-functional team efforts. The RPM is accountable for planning budgeting executing controlling and reporting the functional regulatory activities. This individual provides operational and program management leadership to the Global Regulatory Teams (GRTs) and Project Management Teams (PMTs) within Established Products.

• Lead operationalization of the regulatory strategy in collaboration with the GRT and PMT. Translate the regulatory strategy and requirements into an executable plan with realistic deliverables at a level of detail that allows team members to understand what is critical at any one time.

• Develop maintain and drive execution of regulatory plans. Develop and maintain key event maps that include worldwide submissions and approvals (GFLS) preparations for Health Authority interactions and responses and additional major regulatory milestones and cross-functional deliverables. Ensure with functional teams that all deliverables have clear accountability. Maintain a close eye on the critical path and associated analytics. Communicate timelines for final document approvals to Submission Manager for publishing activities.

• Work out regulatory scenarios and deliver reports to support decision making in line with the Regulatory and Compound Development Team (CDT) strategy.

• Liaise with the CDT PML and Program Coordinator to ensure alignment of the regulatory strategy and plan with the CDT strategy and plan. Establish cross-functional interdependencies with other functional teams. Serve as primary liaison between the PMT and GRT and represent the GRT at the PMT.

• Manage the Regulatory planning activities in the Planisware program schedule and Microsoft Projects.

• Develop maintain and communicate resource requirements (FTE) and out of pocket (OOP) budgets for the regulatory part of the project plan / Line items in the planning system (Planisware (PLW)). Ensure budgets and actuals (both FTE and OOP) are correctly aligned to external or internal resourcing on a monthly basis (WBS code alignment) per Regulatory work packages included in PLW.

• Lead regulatory risk management including the proactive identification of risks and development of mitigation plans and issue management. Appropriately communicate risks with cross-functional impact to the PMT.

• Actively follow up on and report progress concerning regulatory deliverables and milestones e.g. concerning Health Authority interactions and submissions etc.

• Support the Global Regulatory Leader (GRL) and regulatory functions. Co-lead Rapid Response Team (RRT) meetings with the GRL. Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team.

• Co-lead regulatory aspects of the transition of products from the Therapeutic Areas to Established Products. Deliver a regulatory plan and key milestones for the transition. Ensure transfer of information from TA regulatory personnel to EP regulatory personnel. Identify and bridge gaps that occur with the separation of TA and EP regulatory deliverables. Coordinate regulatory activities that are still going on within the TA after the transition has formally been completed.

• Drive process improvements and embed best practices from across programs TA’s and functions into supported teams.

Education and Experience:

• A minimum of a bachelor’s degree is required.

• A post-graduate degree in life sciences business management regulatory affairs or related field is highly preferred.

• Regulatory certification (RAC) is preferred.

• A minimum of 5 years of industry/regulatory experience including a minimum of three years in pharmaceutical R&D or comparable R&D sector.

• Experience in strategic planning development of regulatory strategy and cross functional management of global regulatory submissions and processes (e.g. NDA MAA and lifecycle documents)

• Leadership and management of global submission teams in a matrixed setting with demonstrated ability to drive and expedite team decision making and translate strategy to clear executable action plan.

• Demonstrated experience conducting business process scenario and critical path analysis.

• Demonstrated understanding of Global Regulatory Affairs processes

• Knowledge of global regulations guidelines and regulatory requirements

• Proficiency in the application of project management standards planning and visualization tools (MSP experience highly preferred).

• Demonstrated ability to resolve controversy and influence teams without formal authority.

• Planisware and Microsoft Projects.

• PMP certification.

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

Key words: Project Manager Plainsware PMP Global Regulatory Affairs RAC Documentation R&D

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