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Assistant Manager Regulatory Affairs (LEC)

3.00 to 5.00 Years   Chennai   14 Aug, 2019
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

Job Description

  • 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).
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Keyskills :
bankingsalesmisaccountsommontechnicaldocumentlegislativerelationsimpactassessmentregulatoryrequirements

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