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Pfizer Hiring for Associate – II at Chennai, Tamil Nadu Full Time
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 (Power 2 Learn).
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 (Power 2 Learn).
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.
Regulatory Affairs
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