Regulatory Affairs Specialist

4 weeks ago


Ahmedabad, Gujarat, India Ikamate HR India Pvt Full time

We are seeking a skilled Regulatory Affairs Specialist to join our team at Ikamate HR India Pvt. This role is responsible for preparing and reviewing dossiers in various formats for the ROW market, as well as coordinating with QA/QC departments and local regulatory authorities.

Key Responsibilities:

  • Preparation and submission of Site GMP Applications and Product Registrations
  • Liaisoning with Local FDA and CDSCO for product permissions and certifications
  • Artwork designing for registration sample preparation and submission
  • Preparation and review of technical documents, including BMR, PVP/PVR, and Specification
  • Document preparation for national and international tenders

Requirements:

  • B.Pharm, M.Pharm, or D.Pharm qualification
  • 2-3 years of experience in regulatory documentation
  • Excellent communication and coordination skills

Salary: 20k to 25k CTC



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