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Deputy Manager

2.00 to 6.00 Years   Chennai   25 May, 2020
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

  • Manages the day to day assigned work activities of various complexities including complex deliverables.
  • Provides review support and guidance to the team on need basis.
  • Collaborates with relevant stakeholders which include GRS-CMCs, RRHS of multiple regions, site CNMs, COQAs, ADT team members, HSMs and RCMs.
  • Reviews proposed changes/ regulatory activities mandated by HAs including harmonization of dossiers for completeness and accuracy and development of initial global regulatory strategy while considering registered content in collaboration with RRHS and GRS-CMCs.
  • Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMC GRS 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 GRS and/or appropriate leadership
  • Represents HBU-GRA CMC point of view and meets with key stakeholders to resolve challenges.
  • 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 GRS.
  • Maintains conformance systems maintenance in support of the CMC GRS.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs,

Keyskills :
mis customerservice documentation finance insurance equalemploymentopportunity documentreview regulatoryaffairs legislativerelations it m3 spa agency strategy management regulatory maintenance mc pdm adt

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