JOB SUMMARY

Functions as a Strategist for Brands-LEC team, working with Global Regulatory Strategist (GRS-CMC) and Cross Functional Teams to prepare and submit the variations for entity name change across global markets including US, EU & ROW as per defined timelines.

JOB RESPONSIBILITIES

· Manages day-to-day regulatory activities associated with assigned LEC variations within agreed upon timelines.
· Evaluate change controls for completeness, accuracy and required supporting documents. Initiate change controls when needed.
· Performs Market Impact Assessment (MIA) for the specific entity name change.
· Runs the Reg Atlas to determine the filing action and impacted sections specific for entity name change and to obtain confirmation from the Regional Regulatory Lead.
· 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.




· Should be familiar with submission grouping practices.
· Interpret and global/regional CMC regulatory policies.
· Request documents from the sites/markets/center functions as needed.
· Request Ancillary documents from Ancillary documents team.
· Communicate with markets if clarification/prioritization is needed.
· Follow up with all responsible disciplines to be able to meet timelines.
· Authoring of the impacted CMC sections i.e. Module 3 under the guidance from the product strategists as appropriate and within agreed timelines.
· Responsible for obtaining approval in Reg-459 form from GRS CMCs on the completion of authoring the sections.
· Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, PEARL, RegAtlas, Rosetta etc., as appropriate.
· Must be extremely organized as LEC projects can run across multiple products/markets.
· Ensures compliance to Pfizer internal procedures and training SOPs.
· Ownership of process i

📌 Associate Manager I (Chennai)
🏢 Pfizer
📍 Chennai