Hyderabad; M.Pharm; Regulatory Affairs-TM; Dr.Reddy's

Job Responsibilities
• 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.

Exp:

M.Pham with 2-4 years of relevant experience supporting Europien or RoW Region

send resume: talent@drreddys.com