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Manager

3.00 to 5.00 Years   Chennai   26 Mar, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Manages the day to day work activities associated with projects assigned to the team and self.
  • Provides review support and guidance to the team in impact assessment of regulatory changes, preparation of regulatory strategy and supplement/variation authoring.
  • Primary accountable for managing multiple projects/ CMC programs of various complexities, managing and ensuring daily delivery of regulatory and strategic activities, post-approval changes for Brands in collaboration with Global Regulatory Strategists CMC (GRSs-CMC) assigned to the team.
  • For individual projects, reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.
  • Provides adequate support and guidance to the team in terms of being resourceful on technical and regulatory knowledge.
  • Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges. Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e. Module 1, Module 2.3, M3.2 S/P/R under guidance from the CMC GRL as appropriate and within agreed timelines.
    • Major and Emerging Market focused
    • Reviews technical/supportive information for submission to support change
    • Reviews and applies pertinent global regulatory guidelines
    • Develops technical justification of change for agency submission
    • Updates M3 dossier
    • Coordinates M3.2.R Ancillary documents
    • Flags identified risks to the CMC GRL and/or appropriate leadership
  • Ensures resolution of issues and manages regulatory risks within project. Investigates opportunities for regulatory innovation / promote the use of novel approaches to resolve issues and problems.
  • Responsible for ensuring compliance to Company s submission standards, policies and procedures for self and team.
  • Contributes to the development of internal policies, processes and procedures
  • Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel.
    • 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.
    • Maintains conformance systems maintenance in support of the CMC GRL.
    • Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects
,

Keyskills :
equal employment opportunitydocument reviewimpact assessmentregulatory affairslegislative relationsspaagencycmcpdm

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