Executive - Regulatory Affairs - USV Pharmaceutical Ltd.

By: Pharma Jobs | Views: 6062 | Date: 12-May-2012

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.

USV Pharmaceutical Limited


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 Profile

USV 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 Details


Executive Name:
Reena Bhole

Contact Company:
USV Limited

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