Assistant Manager - Regulatory Affairs – Strategy Team

Novumgen Limited; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Novumgen Limited is seeking an experienced regulatory expert to lead submissions, ensure compliance for commercial products, and drive CMC strategies for EU/UK/US/Canada markets.

The role involves acting as the global regulatory SPOC, guiding cross-functional teams, managing agency interactions, and mitigating regulatory risks throughout development and post-approval activities.

Qualifications

• Experience: 6+ years in regulatory affairs with exposure to global submissions.
• Leads preparation of CMC information for regulatory submissions and risk mitigation.
• Provides regulatory direction for registrations and post-approval activities.

Responsibilities

• In-licensing due diligence and timely circulation of assessment reports.
• UK, EU, US and Canada dossier review and submission support.
• Review GMP documents of contract manufacturers and tech transfer data.
• Develop and communicate regulatory strategies for new products.

Skills

Regulatory affairs

CMC submissions

Cross-functional collaboration

Regulatory strategy

Job description

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.
• Timely submission and approval of Marketing authorizations.
• Responsible for all business query response