Work as Reg CMC Strategy Associate at Pfizer

Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Post : Associate I– Reg CMC Strategy (LEC Team)

Job Summary
Functions as a Strategist for the Brands-LEC team, working 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, as per defined timelines.

Job Responsibilities
• Manages day-to-day regulatory activities associated with assigned LEC variations within agreed-upon timelines.
• Evaluates change controls for completeness, accuracy, and required supporting documents. Initiates change controls when needed.
• Performs Market Impact Assessment (MIA) for the specific entity name change.
• Runs RegAtlas to determine the filing action and impacted sections specific to the entity name change and to obtain confirmation from the Regional Regulatory Lead.
• Searches regulatory databases for Common Technical Document (CTD) components or requests them from appropriate market contacts when not available.
• Maintains familiarity with global guidelines for filing Legal Entity Changes (LEC) and runs corresponding reports in the regulatory requirements database.
• Maintains familiarity with submission grouping practices.
• Interprets and applies global/regional CMC regulatory policies.

• Requests documents from sites, markets, and center functions as needed.
• Requests ancillary documents from the Ancillary Documents team.
• Communicates with markets if clarification or prioritization is needed.
• Follows up with all responsible disciplines to ensure timelines are met.
• Authors the impacted CMC sections, i.e., Module 3, under the guidance of the Product Strategists, as appropriate and within agreed-upon timelines.
• Is responsible for obtaining approval in the Reg-459 form from GRS-CMCs upon completion of authoring the sections.
• Utilizes Pfizer's CMC systems, i.e., GDMS, PDM, SPA, PEARL, RegAtlas, Rosetta, etc., as appropriate.
• Works under the supervision of the Line Manager.
• Ensures compliance with Pfizer's internal procedures, training requirements, and SOPs.

Candidate Profile
• Minimum : Postgraduate degree in Pharmacy.
• 0–1 year of experience in independently leading activities within the Regulatory Sciences function in a reputed pharmaceutical organization.
• Knowledge of NDAs, ANDAs, MAAs, CTDs, and other regulatory components.

Preferred Attributes
• Excellent oral and written English communication skills.
• Good conceptual, analytical, problem-solving, reasoning, and organizational skills.
• Ability to adapt to change and prioritize projects with minimal guidance.
• Strong attention to detail and accuracy.

Additional Information
Experience : 0–1 year
Qualification : Postgraduate degree in Pharmacy
Location : Chennai, Pfizer Centre
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CMC Strategy
End Date : 10th October 2026