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+ Manages the day to day work activities of the team along with the regulatory activities associated with projects assigned to the team and self.

+ Responsible for the deliverables of the team

+ Provides review support and guidance to the team in impact assessment of regulatory changes, preparation of regulatory strategy and supplement/variation authoring.

+ Primary accountable for managing multiple projects/ CMC programs of various complexities, managing and ensuring daily delivery of regulatory and strategic activities, post-approval changes for Brands in collaboration with Global Regulatory Strategists -CMC (GRSs-CMC) assigned to the team.

+ For individual projects, reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.

+ Provides adequate support and guidance to the team in terms of being resourceful on technical and regulatory knowledge.

+ Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges. Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e. Module 1, Module 2.3, M3.2 S/P/R under guidance from the CMC GRL as appropriate and within agreed timelines.

+ Major and Emerging Market focused

+ Reviews technical/supportive information for submission to support change

+ Reviews and applies pertinent global regulatory guidelines

+ Develops technical justification of change for agency submission

+ Updates M3 dossier

+ Coordinates M3.2.R Ancillary documents

+ Flags identified risks to the CMC GRL and/or appropriate leadership

+ Ensures resolution of issues and manages regulatory risks within project. Investigates opportunities for regulatory innovation / promote the use of novel approaches to resolve issues and problems.

+ Responsible for ensuring compliance to Company's submission standards, policies and procedures for self and team.

+ Contributes to the development of internal policies, processes and procedures

+ Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.

+ Coordinates internal document review and sign off.

+ Utilizes Pfizer's CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate

+ Supports Query and/or commitment management in collaboration with


+ Maintains conformance systems maintenance in support of the CMC GRL.

+ Remains knowledgeable about current regulations and guidance, interprets

and implements in the assigned projects

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs

Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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