Sr. Executive / Assistant Manager - Regulatory Affairs ( API )

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Sr. Executive / Assistant Manager - Regulatory Affairs ( API )

work outline icon6 - 10 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

FDC Limited

time outline iconMumbai, Maharashtra, India

Posted on 22-11-2021

115 Views

1 Vacancy

Description

  • For APIs Markets, to develop regulatory strategies, implementation plan.
  • Preparation and submission of CEP and its revisions, new DMFs & amendments, for US, Europe and all other regions.
  • Various overseas and local customers requirements compliances.
  • Review of documents, cross functional team communication.
  • Good Knowledge of ICH and other Regulatory guidelines, aware of good documentation practices.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

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