Regulatory Affairs – Strategy Team

Post Approvals – UK / EU

Position: Senior Executive / Assistant Manager

Experience: 6+ years

Job Responsibilities:

• Regulatory expert responsible for the submissions, RFIs and compliance activities commercial products supporting Business Unit.
• Leads the preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops mitigation plans.
• Provide regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities, for regional products registered specifically for EU/AU/CA/UK markets.
• Acts as the SPOC for Strategy Alliance Team - Global regulatory representative within cross-functional teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic regulatory decisions.
• Accountable for interactions with regulatory agencies and external partners either directly or in conjunction with other stake holders.




• Operate independently to resolve issues and manage regulatory risks and ambiguous situations within project teams.
• Investigates opportunities for regulatory innovation / promote the use of novel approaches within project team to resolve issues and problems. May take appropriate risk to achieve desired results.

Details of the job responsibilities to be performed

• In-licensing product due diligence and timely circulation of the assessment reports.
• UK, EU, US and Canada dossier review and submission.
• Provide regulatory support to cross functional teams.
• Review of Tech Transfer documents and Product development data.
• Review of GMP documents of Contract Manufacturers.
• Preparation and review of regulatory strategy documents for newly introduced products.
• Communicate with different regulatory agencies and partners for timely information availability.
• eCTD development support for different regions.
• Timely s

📌 Assistant Manager (Vadodara)
🏢 Novumgen
📍 Vadodara