We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs & Formulations and Branded generics. We have also ventured in a cosmoceutical business recently.
We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs & Formulations and Branded generics. We have also ventured in a cosmoceutical business recently.
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.
Salary:Compensation will be at par with industry standards
Industry:Pharma, Biotechnology, Clinical Research
Functional Area:Legal
Role Category:Drug Regulatory Affairs/ Documentation
Role:Regulatory Affairs Manager
Keyskills:API, DMF, US, Canada, Auatralia
Desired Candidate Profile
Education:(UG - B.Sc) AND (PG - M.Sc - Chemistry)
Please refer to the Job description above
Company ProfileUSV Limited
www.usvindia.com
We are a leading health care company with the following areas of focus: Branded Generics, Active Pharmaceutical Ingredients (APIs & Formulation) and Bio-similars. Sixty-eight percent of our business is contributed by the India operations and the rest by export of APIs & Formulations and Branded generics. We have also ventured in a cosmoceutical business recently.
Contact DetailsExecutive Name:Reena Bhole
Contact Company:USV Limited