Career in USV as Assistant Manager - Regulatory Affairs -API
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 (API)
- Preparation of Technical Packages
- Preparation of DMFs in CTD format for registartion in regulated market Europe, USA, Japan, Canada, Australia etc
- Keeping existing DMFs in current status
- Filing of Annual reports, DMF amendments
- To prepare response to deficiency letters from Health Authorities.
- Checking documents recived for DMF filing as per current regulatory requirements
- Review of Analytic\al method validation documents for EU/US DMF filings for accuracy and recommend corrections as per latest ICH requirements.
- Timely regulatory support/advice to all API site / formulation sites.
- To train API sites for Drug Master file documentation.
- Maintenance of various lists / document submission records, communications DMF submission records.
- Co - ordination with QA/Production/Development for documents required for DMF filing.
- Conducting regulatory trainings for subordinates, plant and other departments.
- Must have experience of atleat 5-6 years in API regulatory.
- To build in new systems within the group. Responsible for new initiativesand ideas.
- Leadership qualities, positive approach, Handle the team of 4-5 subordinates.
Experience: min. 6 years
Education: B.Pharm, M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
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