Description
As a CMC strategist, you will develop CMC regulatory strategies, submissions, and compliance activities for commercial pharmaceutical products. You will provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post-approval activities.
Key responsibilities include:
- Preparing CMC information for submission to global regulatory agencies
- Generating and driving CMC strategies
- Assessing risks and developing contingency/mitigation plans
- Acting as the global CMC representative within cross-functional project teams
- Interpreting regulations and guidelines and assessing global implications for strategic CMC decisions
- Managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities
- Resolving issues and managing regulatory risks within project teams
- Making decisions to resolve moderate problems in standard situations
- Ensuring compliance with Pfizer's training activities and individual development plans
- Utilizing Pfizer's CMC systems, such as GDMS, PDM, SPA, and Rosetta
This is a hybrid role, requiring you to work from Pfizer's office in Chennai, India, with some flexibility for remote work.