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Tuesday, December 11, 2012

Opening for Officers - Regulatory Affairs Leonine Consultants - Chennai, Tamil Nadu

Greetings from Leonine Consultants.

We are looking out for some experienced officers in RA, Pharma domain to work with one of our Pharma Client.
Please find below the brief JD for Officer - RA.

Work Location -
- Up to 3.50L

Basic Knowledge of the Regulatory Affairs activities in active drug substance manufacturing facilities
- Technically must know the active drug manufacturing process and analytical method development process.
- Well versed with eCTD requirements and paper/electronic submissions to all regulatory agencies (web based filings)
- Review of the regulatory submission lab development reports, batch manufacturing records, analytical documents, specifications, test procedures, validation documents etc.
- Basic chemistry knowledge in regards to the use of solvents, intermediates etc in the manufacturing facilities.
- Minimum 1 to 3 years of work experience in Regulatory Affairs (API) department with DMF/CEP submissions.
- Work experience in regulatory compliance will be an added advantage

If interested please contact Deepthi @ 9543180409

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