USV is aleading healthcare company with the following areas of focus: Generics, Active Pharmaceutical Ingredients (APIs) and Biosimilars. 68% of our business is contributed by India Operations and the rest by export of APIs and Generics.
USV is a 48 year old healthcare company which began as a joint venture with USV&P Inc, a subsidiary of Revlon. Product range consists of Generics, Active Pharmaceutical Ingredients and Biotherapeutics that are manufactured in our modern cGMP compliant plants located in India.
Post: Executive - Regulatory Affairs
Job Description:
1.Preparation of technical packages.
2. Preparation of DMF's in CTD format for registration in regulated market Europe, USA, Japan, Canada, Australia etc.
3. Maintaining DMF status.
4. Filing of Annual Reports, DMF amendments
5. Compilation and review of plant and R&D documents
6. Response to letters from various health authorities
7. Checking/reviewing of documents received for DMF filing as per regulatory requirements
8. Guide site for regulatory filing documentation
9. Maintenance of lists/documents/records, communications, DMF submission records.
10. Co-ordinate with QA/production/ development for documents required for DMF filing.
11. Timely regulatory support to all API site / formulation sites.
12. To train API sites for Drug Master file documentation.
Candidate Profile:
- Must have prior experience of API (DMF) regulatory filings.
- Must have experience e-CTD submission.
- Must have thorough knowledge of ICH / USFDA / EU
- Regulatory experience in regulated markets,knowledge of various country requirements,ICH
Additional Information:
Experience: 3-4 years
Location: Mumbai
Education: B.Pharm, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
To apply for this position, please forward your CV to, hrd@usv.co.in
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