Senior Executive
Pfizer Canada Inc.
Chennai, India
7d ago

Job responsibilities includes 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 CMC GRL.
  • 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 CMC GRL.
  • Authors and / or compiles CMC contributions for renewals, i.e. Module 1, 2.3, M3.2S / P / R under guidance from the CMC GRL 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.
  • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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