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- 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 Regulatory Requirement Manager 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 CMC GRL as appropriate and within agreed timelines.
- Responsible for obtaining the approval in Reg-459 form from GRL on the completion of authoring the sections.
- Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, 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
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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