Regulatory Affairs

15 hours ago

Hyderabad, Telangana, India Biological E Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Regulatory Affairs Job Opportunity

Desired Experience : 3- 9 years

Job Location : Genome Valley, Shameerpet, Hyderabad

Preferred Industry : Vaccines / Biotech

Designation: Senior Executive/ Executive

Qualification: M. Pharmacy/ M. Sc/ B. Pharmacy

Job Responsibilities:

  • Responsible for Regulatory submission to Indian NRA, Emerging Markets, Regulated Markets and World Health Organization.
  • Experienced in handling, management and expansion of product portfolios, markets/ territories.
  • Experienced in the preparation, review and submission of applications/ response to RCGM vide IBSC.
  • Expertise in preparation, compilation and submission of Indian NRA applications (Eg: Form CT 10, 16, CT18, 40, 10, Export NoC, etc., but not limited)
  • Well versed with Indian NRA submission portals, IBKP, SUGAM, NSWS, ODLS/ ONDLS, etc.
  • Author, review and compilation of Regulatory Packages like Briefing documents, Scientific package, Pre-IND packages, Clinical Trial, Expedited request, Pre-qualifications, etc.
  • Author, review, compile and submission of Marketing Authorization Applications (CTD/ ACTD/ eCTD) in India, Emerging Markets, Regulated Markets and Vaccine Prequalification Dossier to WHO.
  • Application for Post Approval Change(s), Variations and Comparability packages
  • Author, review and submission of responses to India, EM, WHO and Regulated markets..
  • Hands-on experience with MS office tools, PDF, Track Wise, DMS, Veeva Vault, Lorenz/ Pharma ready, etc..
  • Handling the Health Agency audits for India, EM, Regulated and WHO inspections
  • Coordination with cross functional departments like QA, QC, Production, Warehouse, Distribution, Marketing and various teams (Internal & External).
  • Review of Artworks (Labels and Package Insert) and Pack Profiles.
  • Any other regulatory support required by the organization per submission need.

Interested Candidates having relevant experience can send in their CVs to by mention the subject as Applying for "Regulatory Affairs"

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