Executive Senior Executive -Analytical Development

Role & Responsibilities:
• Coordinate and respond to analytical queries received from regulatory agencies for US, OAM, and EM markets
• Ensure timely inputs from Analytical Development to Regulatory teams for agency responses
• Revise specifications and Standard Test Procedures (STP) in line with regulatory query responses
• Review pharmacopoeial updates from IP, USP, BP, and EP on a regular basis
• Perform gap assessments for pharmacopoeial changes and share impact analysis
• Evaluate pharmacopoeial changes and revise related specifications and STPs accordingly
• Review and release excipient specifications and STPs for new development, LCM, and market extension projects
• Manage excipient reviews for new projects and lifecycle management (LCM) activities
• Prepare analytical specifications, Analytical Test Procedures (ATP), and STPs for:
– New drug products and APIs
– Vendor additions and updates
– Pharmacopoeial updates
– Lifecycle changes
• Provide analytical support to FRD, Regulatory Affairs, AD, and manufacturing plants
• Review vendor documentation for outsourced APIs
• Track multiple documents under review and approval with cross-functional stakeholders to ensure timely release

Qualification:
• M.Pharm or M.Sc (Analytical / Pharmaceutical Sciences preferred)

Experience:
• 3–8 years of relevant experience in Analytical Development within the pharmaceutical industry

Skills:
• Analytical Development & Documentation
• Pharmacopoeial Compliance (IP, USP, BP, EP)
• Regulatory Query Management
• Specification & STP / ATP Preparation
• Lifecycle Management (LCM) Support
• Cross-functional Coordination
• Attention to Detail & Time Management

About the Company:
• Sun Pharmaceutical Industries Ltd is India’s largest pharmaceutical company and a leading global specialty generics organization, committed to quality, innovation, and regulatory excellence while fostering a culture of growth, ownership, and collaboration.