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: Assistant Manager - Regulatory Affairs (EU)
Job Description:
- Preparation of registration dossiers in CTD format.
- Compilation and review of variation applications for EU agencies.
- To prepare response to deficiency letters from agency.
- Thorough knowledge of filing procedures in EU territory .
- Checking documents received for dossier compilation as per current regulatory requirements.
- Review of Analytical method validation documents for formulations for accuracy and recommend corrections as per latest ICH requirements.
- Timely regulatory support / advice to all departments / formulation sites.
- To guide site for regulatory filing documentation.
- Manintenance of various lists / document submission records, communications.
- Co-ordination with QA / Production / Development for documents required for DMF filing.
Candidate Profile:
- Candidate must have experience of around 6 years in European filings of formulations.
- Good communication skills (oral & written) are must.
- To build in new systems within the group.
- Responsible for new initiatives and ideas.
Additional Information:
Experience: min. 6 years
Location: Mumbai
Education: B.Pharm, M.Pharm
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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