1+ months

Assistant Manager

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Functions as an individual contributor responsible for managing end to end post approval changes and related regulatory activities

+ 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.

+ Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRS.

+ Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e.Module 1, Module 2.3, M3.2S/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 GRS and/or appropriate leadership

+ Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges.

+ 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 CMC GRS.

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

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: 2020-02-07 Expires: 2020-07-09
Sponsored by:
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Assistant Manager


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