Regulatory Affairs Biosimilars/Biologics | Sun Pharma | Gurgaon

HR / Admin / Office, PharmacoVigilance / Regulatory Affairs
Haryana, Delhi NCR
October 17, 2023
Full Time
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Job Overview

  • Date Posted
    October 17, 2023
  • Location (State / UT)
    Haryana, Delhi NCR
  • Expiration date
    December 13, 2024
  • Experience
    3 Years, 7 Years
  • Gender
    Any
  • Desired Qualification
    Bachelor Degree

Job Description

Role & Responsibilities:

  • Experience in Biologics/Biosimilar Regulatory experience
  • Good understanding of Biologics/Biosimilar Post-approval CMC variations (regulated markets like the US, EU and Japan, ROW experience is a plus)
  • Author Module 3 dossier sections for initial marketing applications/Variations
  • Expansion of approved biologic products to Emerging markets
  • Good understanding of Biologics product development technical aspects & regulatory expectations (ICH guidance, FDA, EMA guidance )
  • Good communication skills and coordination skills.

Skills:- Regulatory Affairs, DMF (Drug Master File), DMF dossier preparation, USFDA, Biosimilars, Europe, Dossiers, CMC, US Market

Experience: 3 to 7 Years

Location:- Gurgaon

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