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Executive Regulatory Affairs | Pfizer India | Chennai, India


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Position: Executive Regulatory Affairs

Location: Chennai, Tamil Nadu

Job Description:

Job responsibilities include the following but not limited to:

  • Preparation of the CMC contributions for Renewal applications for the assigned products for global markets
  • Liaise with Pfizer Global Supply and other support functions as needed.
  • Use of regulatory systems and management of CMC documentation and information in support of the GRS-CMC.
  • Manages the day to day work activities associated with assigned renewal applications within agreed-upon timelines.
  • Reviews and applies pertinent  regulatory guidelines  for authoring renewals
  • Develops initial renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC.
  • Authors and/or compiles CMC contributions for renewals, i.e. Module 1, 2.3, M3.2S/P/R under guidance from the GRS-CMC as appropriate and within agreed timelines.
  • Reviews technical/supportive information for submission to support renewals

  • Develops technical justification of change for agency submission as needed
  • Updates impacted dossier components as needed
  • Coordinates M3.2.R Ancillary documents as needed
  • Escalates delays in timelines and flags identified risks to the CMC GRL and/or appropriate leadership
  • Coordinates internal document review and sign off.
  • Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate.
  • Supports Query and/or commitment management in collaboration with CMC GRL.
  • Ensure compliance with assigned P2L and Pfizer compliance training.

Qualification: B.Pharma/M.Pharma

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