Executive - Regulatory Affairs

Sun Pharma is seeking an Executive to be responsible for Regulatory Affairs, including new product submissions, renewals, responses to queries, and lifecycle management for MENA markets. This role involves preparing and reviewing quality dossiers, ensuring compliance with regulatory requirements, and managing product information. They offer a supportive community and focus on personal and professional growth.

Requirements

• Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.
• Review documents (Development report, scale up report, specification, stability protocol) before initiation of Exhibit batches.
• Prepare and review responses to deficiency enabling approval of products filed to regulatory agency.
• Prepare and review variations as per country specific requirements to support approval of changes
• Ensure reposition of comprehensive product information into central repository.
• Review regulatory filing impact of variations, change controls, etc.

Benefits

• Robust benefits and opportunities for personal and professional growth.
• Supportive community