Associate - Drug Regulatory Strategy ( TAPS )

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Associate - Drug Regulatory Strategy ( TAPS )

work outline icon3 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Pfizer Healthcare India Private Limited (PHIPL)

time outline iconChennai, Tamil Nadu, India

Posted on 24-12-2021

1 Vacancy

Description

  • The role works with some independence under limited supervision to provide strategic and operational regulatory direction and may support Global Regulatory Leads through development, registration and approval/post approval. - Provide regulatory support for assigned responsibilities as an individual contributor, directly accountable for providing support to Global Regulatory Leads.
  • Day to day provision of general assistance to Global Reg Leads (GRLS) in the compilation of regulatory dossiers, coordination of marketing applications and responding to regulatory questions received from health authorities, as well as compilations of responses to queries that can serve multiple purposes.
  • Manage regulatory aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies.
  • Provide support for the Regional Reg Strategy, contribution to the Global Reg Team that aligns with regional business needs.
  • Supporting clinical development related activities (END, CTA) Represent Reg Team and contribute aligned (ie with other regional players) regional strategy.

Category

Others

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