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About Company

We are leading Distributors of Excipients for Topical / Ophthalmic & Parenteral dosage forms. All major Biopharmaceutical companies in India

Position Name :

Regulatory Affairs Associate

Organization :

Pharmonix Biologicals


B.Pharm, M.Pharm, Msc, BSc


1 to 2 Years


25,000 - 35,000 /month



Skills: Regulatory Submissions, Electronic Common Technical Document (eCTD), Guidelines/GMP/Testing Methods for Excipients, Vendor Management


  • Manage entire regulatory documentation for excipients.
  • Resolve technical queries from major pharmaceutical clients.
  • Handle technical matters and documentation for excipient manufacturers.
  • Prepare in-house technical documents for excipient product promotion.
  • Understand and provide specific technical documents for manufacturer and product qualification.
  • Handle regulatory qualification documents and queries for excipients/in-actives.
  • Coordinate with excipients/in-actives manufacturers overseas.
  • Compare USP/EP/JP monographs for various excipients/in-actives.
  • Prepare documents for pharmaceutical companies regarding excipients qualification.
  • Manage virtual audits of pharmaceutical customers concerning excipients qualification.
  • Oversee vendor qualification process end-to-end for excipient raw material products.

Preferred Background:

  • Pharma industry experience is preferred.
  • Strong technical know-how regarding guidelines, GMP, and testing methods for excipients.
  • Vendor management experience.

Remuneration: Competitive, with industry-leading benefits.

Application Link

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