About Us:

An established player in the B2B Pharma raw material space has recently launched an exciting recent E-commerce platform – CLYZO

Position- Regulatory Affairs Associate

:

An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having experience and knowledge of handling technical queries and regulatory documentation.

Responsibilities:
Handling entire regulatory documents of excipients.
Resolving technical queries of big pharmaceutical clients
Handling technical matters & document related work of excipient manufacturer.
Preparation of in house technical documents, required for promotion of excipient products.
Should be able to understand & provide specific technical documents, for manufacturer & product qualification.
Regulatory qualification documents and queries for Excipients / in-actives,




Co-ordination with Excipients / in-actives manufacturer overseas
USP/EP/JP Monograph comparison for various excipients / in-actives
Preparing documents of Pharmaceutical companies, w.r.t Excipients Qualification
Handling Virtual Audits of Pharma Customers w.r.t Excipients Qualification
Handling Vendor Qualification Process end to end for Excipients Raw Material Products.

Skills required:
Positive Technical Know-how, w.r.t Guidelines / GMP / Testing Methods (for Excipients)
Vendor management experience
Minimum 2 years of experience into similar role
Candidates from Pharma background will be preferred.

Remuneration and perks will be best in industry.

If you feel you are right fit for this role, please apply we would love to connect with you!

📌 Regulatory Affairs Associate Thane
🏢 Pharmonix Biologicals
📍 Thane