Associate Ii

1 week ago


Chennai, India Pfizer Full time

Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changes globally in collaboration with the CMC GRS.- Global regulatory strategy development in collaboration with the CMC GRS.- Liaise with Pfizer Global Supply and other support functions as needed.- Use of regulatory systems and management of CMC documentation and information in support of the CMC GRS.

JOB RESPONSIBILITIES
- 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 GRS 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 GRA 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.

Work Location Assignment: On Premise

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

Regulatory Affairs


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