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