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Senior Regulatory Affairs Executive
2 weeks ago
Greetings from Milan Laboratories (India) Pvt. Ltd.
Currently we are hiring for Senior Executive - RA at the Panvel location.
Below are the requirements:
- Qualification: B.Pharm/M.Pharm/Diploma in RA
- Experience: 8 to 11 years in Pharmaceutical industry - Formulations
- Job location: Kamothe, Panvel
- No of vacancy: 1
Role & responsibilities
Preparation & Compilation of registration dossiers for non-regulated, semi regulated and regulated markets.
Collection of dossier documents from various departments like QC, QA, Stores, Production, FD, Stability and maintaining in a master document with systematic manner.
Submitting and reviewing the technical requirements for Tender Filing
Review of specifications as per monographs. (USP/Ph.Eur).
Review of process qualification and product development records.
Review of stability data.
Review of innovator comparative dissolution data.
Review of all documents related to Formulation Development.
Artwork review and approval
Review, submission of quality dossiers as per the current guideline (country specific) requirements and attending the MOH query.
Document follow up for FDA/Regulatory Queries
Raising applications for product license, COPP, FSC as per requirement.
Communication with customer for the country specific registration requirements.
Required ECTD experince
Interested candidates can share their resume at:
- Email ID:
- WhatsApp:
Best Regards
Ranna Bhatt
Senior Executive- HR
Milan Laboratories (India) Pvt. Ltd.