Edge Pharmaceuticals is seeking experienced, immediate Joiner Regulatory Affairs professionals to join their team in Mumbai. The ideal candidate should have experience in the Regulatory Affairs field within the ROW markets. Experience in TP/ CMO and QC testing will be an added advantage.
About Edge Pharmaceuticals
The Edge Pharmaceutical Group is a privately owned global pharmaceutical company, centred around strategic affiliations in key markets and with a strong heritage in the development, manufacturing, registration, and supply of healthcare products.
As part of its global roll-out, Edge has created a specifically, and strategically, focussed structure to service the United Kingdom and Europe. Given the implications around Brexit, Edge is registered in the UK and Ireland.
Job Responsibilities
- Preparation & review of dossiers in CTD & country specific format for ROW market.
- Review of the quality and analytical data as per the Pharmacopoeial specification for the purpose of compilation of the dossier
- Review of regulatory documents (COPP, PP, FSC, GMP).
- Review of the documents required for dossier (viz analytical report, PVP, PVR, PDR, MFR, SSP, stability data & Cumulative Dissolution Profile).
- Preparation of various pharmacological pre-clinical & toxicological data based on published paper.
- Preparation/review of SmPC, Primary & Secondary packaging, PIL.
- Handling of various queries with timely submission raised by Regulatory Authority.
Artwork checking as per country guidelines
The job responsibilities may vary as per the need.
How to Apply?
If you meet the above qualifications and are passionate about regulatory compliance, we’d love to hear from you!
Interested candidates can share their CV at: Email: Swattereg@gmail.com
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for Pharma Students by a Pharmacist