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.