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At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer

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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