This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. 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 apply 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

📌 Associate Manager I (Chennai)
🏢 Pfizer
📍 Chennai