Pharmonix Biologicals Hiring in Regulatory Affairs

Job Posting: Regulatory Affairs Associate at Pharmonix Biologicals, Thane

About Pharmonix Biologicals

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Pharmonix Biologicals is a leading distributor of excipients for topical, ophthalmic, and parenteral dosage forms, serving major biopharmaceutical companies in India.

Position: Regulatory Affairs Associate

Organization: Pharmonix Biologicals
Location: Thane
Salary: ₹25,000 – 35,000 /month
Experience: 1 to 2 Years
Qualification:

  • B.Pharm
  • M.Pharm
  • M.Sc
  • B.Sc

Skills:

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

Responsibilities:

  • 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
  • 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
  • Strong technical know-how regarding guidelines, GMP, and testing methods for excipients
  • Vendor management experience

Remuneration:

Competitive, with industry-leading benefits

How to Apply:

Interested candidates are encouraged to share their CVs at email@example.com


Meta Description:

Join Pharmonix Biologicals as a Regulatory Affairs Associate in Thane. Pharma industry experience preferred. Apply now!

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