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Associate II, Reg CMC Strategy at Pfizer - ApplyBlast

Associate II, Reg CMC Strategy

Pfizer

2 days ago

3.8 on Glassdoor

Chennai, Tamil Nadu, India

Hybrid

Full Time

Medior

0 applicants

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About this role

This role serves as a CMC strategist for developing regulatory strategies, submissions, and compliance activities for commercial pharmaceutical products. The position involves driving global CMC regulatory direction, preparing submission documentation, and assessing risks for assigned projects. The incumbent acts as the global CMC representative within cross-functional teams to ensure strategic decision-making and compliance.

Responsibilities

Develop and drive global CMC regulatory strategies and documentation for assigned projects
Prepare CMC information for submission to global regulatory agencies and manage compliance activities
Act as global CMC representative within cross-functional teams to interpret regulations and assess strategic implications