- Leading the preparation of CMC information for submission to global regulatory agencies.
- Generating and driving CMC strategies, assessing risks, and developing mitigation plans.
- Providing regulatory direction and documentation for assigned projects/products, covering initial registrations and approval/post-approval activities.
- Acting as the global regulatory representative within cross-functional teams, interpreting regulations and guidelines, and assessing global implications for strategic regulatory decisions.
- Accountable for interactions with regulatory agencies and external partners.
- Operating independently to resolve issues and manage regulatory risks within project teams.
- Investigating opportunities for regulatory innovation and promoting the use of novel approaches within project teams.
Are you looking for a career in regulatory affairs within the pharmaceutical industry? Novumgen is offering exciting opportunities for Regulatory Affairs Executive and Senior Executive positions in Vadodara. If you have regulatory experience and a passion for compliance activities and global regulatory strategies, this could be your next career move.
Job Description
Novumgen is seeking Regulatory Affairs professionals who will be responsible for submissions, RFIs, and compliance activities for pharma development and commercial products supporting the Business Unit. Key responsibilities include: