Assistant Manager - Regulatory Affairs Strategy Team

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

1. In-licensing product due diligence and timely circulation of the assessment reports.
2. UK, EU, US and Canada dossier review and submission.
3. Provide regulatory support to cross functional teams.
4. Review of Tech Transfer documents and Product development data.
5. Review of GMP documents of Contract Manufacturers.
6. Preparation and review of regulatory strategy documents for newly introduced products.
7. Communicate with different regulatory agencies and partners for timely information availability.
8. eCTD development support for different regions.
9. Timely submission and approval of Marketing authorizations.
10. Responsible for all business query response