Work as Regulatory Affairs officers - Europe market in Dr. Reddy's Lab
Dr. Reddy's Laboratories (NYSE: RDY) is an emerging global pharmaceutical company with proven research capabilities. The company is vertically integrated with a presence across the pharmaceutical value chain. It produces finished dosage forms, active pharmaceutical ingredients and biotechnology products and markets them globally, with focus on India, US, Europe and Russia. The Company conducts research in the areas of cancer, diabetes, cardiovascular, inflammation and bacterial infection.
Post: Regulatory Affairs officers - Europe market
• Participate in the regulatory activities of full spectrum of formulation development, from clinical trials to marketing to post approval activities.
• Ensure the appropriate licensing, marketing and legal compliance of the finished dosages.
• Review the documents at each stage of formulations development.
• Highlight the regulatory issues that can be there and try to resolve them.
• Coordinate with R&D, AR&D, QA, etc. to collect the complete set of documents.
• Compile the ANDA document to be submitted to FDA.
• Ensure the documents are error free and have minimum deficiencies.
• Prepare annual reports and send them to FDA.
• Manage change controls and deviation controls.
• Keep themselves abreast of international legislation, guidelines and customer practices
• Develop and write clear arguments and explanations for new product licenses and license renewals.
• Advise PDTs on regulatory requirements.
• Respond to the queries of Regulatory authorities and customers on time.
• Review the process change proposals and provide guidance on change proposals.
M.Pharm with 2-4 years of relevant experience for European Markets
Experience: 2-4 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
End Date: 19-01-2011
Business Unit : GRAC
Reference Code : D 771
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