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Associate - Ii

3 months ago

Chennai, Tamil Nadu, India Pfizer 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.
  • 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 Reg459 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

LI-PFE