Associate I– Reg CMC Strategy (LEC Team) at Pfizer
A rare chance for pharmacy graduates to join Pfizer as an Associate I in the Regulatory CMC Strategy (LEC Team) in Chennai, India. This full-time Pfizer Regulatory Affairs Job offers an opportunity to contribute to significant regulatory activities while working with a global team. Applications are open now.
About the company
Pfizer is a leading global pharmaceutical company dedicated to innovating and delivering life-changing medicines. With a commitment to improving health and well-being, Pfizer operates in various therapeutic areas and is known for its strong research and development capabilities. The company is headquartered in New York City, USA, and has a presence in numerous countries worldwide.
Job Details
- Company: Pfizer
- Location: India – Chennai
- Job Type: Full-time
- Posted On: 03 October 2023
- Reference Number: 4964284
Pfizer Regulatory Affairs Job Description
In this Pfizer Regulatory Affairs Job, the Associate I will function as a strategist for the Brands-LEC team, collaborating with the Global Regulatory Strategist (GRS-CMC) and cross-functional teams to prepare and submit variations for entity name changes across global markets, including the US, EU, and ROW, adhering to defined timelines.
Key Responsibilities
- Manage day-to-day regulatory activities associated with assigned LEC variations within agreed timelines.
- Evaluate change controls for completeness, accuracy, and required supporting documents; initiate change controls when necessary.
- Perform Market Impact Assessments (MIA) for specific entity name changes.
- Run the RegAtlas to determine filing actions and impacted sections specific to entity name changes.
- Search regulatory databases for Common Technical Document components or request them from appropriate market contacts when not available.
- Familiarity with global guidelines for filing Legal Entity Changes (LEC) and run corresponding reports in the regulatory requirements database.
- Interpret and apply global/regional CMC regulatory policies.
- Follow up with all responsible disciplines to meet timelines.
Eligibility Criteria
- Minimum – Postgraduate in Pharmacy.
- 0-1 year of experience in leading independently in the Regulatory Sciences function in a reputed pharmaceutical organization.
Required Skills
- Excellent oral and written English communication skills.
- Good conceptual, analytical, problem-solving, reasoning, and organizational skills.
- Attention to detail and accuracy required.
- Basic knowledge of regulatory requirements for post-approval changes for US, EU, and ROW markets.
How to Apply
Interested candidates can apply through the following link: Apply Now
Additional Information
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Conclusion
This Pfizer Regulatory Affairs Job presents an excellent opportunity for pharmacy graduates to engage in meaningful regulatory work that impacts global markets. Qualified candidates are encouraged to apply at the earliest to seize this opportunity.
