Regulatory Affairs Associate

About Us:

https://www.clyzo.com/aboutus

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

Position- Regulatory Affairs Associate

Job Description:

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:

• Good 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 benefits will be best in industry.

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