Work as Regulatory Affairs officers - Europe market in Dr. Reddy's Lab
Post: Regulatory Affairs officers - Europe market
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Job Description:
• 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.
Candidate Profile:
M.Pharm with 2-4 years of relevant experience for European Markets
Additional Information:
Experience: 2-4 years
Location: Hyderabad
Education: M.Pharm
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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