Opening for Group Leader - Regulatory Affairs at Dr. Reddy's Laboratories

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: Group Leader - Regulatory Affairs

Job Description:
• Focus on ROW/Domestic Markets
• Perform as per regulatory filing plan through interaction with GRAC – Formulations Head
• Ensure that the regulatory submissions are made in time, according to the guidelines of various agencies
• Ensure the regulatory submissions are adequate and error free, with minimum open issues
• Close the open issues before filing if possible
• Provide inputs/guidance to the Product Development Teams
• Review the documents received from R&D, DQA, AR&D, etc. at each and every stage of formulation development so that the same can be shared with authorities and customers
• Respond to FDA queries in consultation with Critical Task Force team
• Ensure that the queries from Regulatory authorities or the customers are responded within pre-defined time, with adequacy and accuracy
• Review the process change proposals and provide guidance on change proposals
• Review the various Pharmacopoeial updates that appear in the USP, EP, JP pharmacopoeia, Forum and Supplements and ensure the changes are communicated to the plant and AR&D
• Ensure that various licenses required at various stages of formulation development are obtained and ensure local regulatory compliance
• Responsible for post approval maintenance of regulatory issues

Candidate Profile:
• Number of products developed with product development teams
• Number of queries/deficiencies handled
• Should be able to build sustainable organization capabilities
• Should take responsibility and work with integrity
• Should be good at interpersonal and leadership skills
• Should be able to manage the performance of his team well
• Should have good communication skills
• Interact with team, product development teams, customers and regulatory authorities

Additional Information:
Experience: 6-8 years
Location: Hyderabad
Education: M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 28-02-2011