Job Posting: Regulatory Affairs Associate at Pharmonix Biologicals, Thane
About Pharmonix Biologicals
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!