Regulatory Affairs Manager

Regulatory Affairs Manager

The Regulatory Affairs Manager will lead cross-functional coordination for regulatory submissions, maintain up-to-date knowledge of relevant legislation, and serve as the primary liaison with regulatory agencies.

• Develop and execute regulatory strategies to support product development, approval, and lifecycle management in target markets.
• Prepare, review, and submit regulatory documentation (e.g., INDs, NDAs, ANDAs, DMFs, CTAs, MAAs, 510(k), PMA, CE marking, etc.) to relevant health authorities.
• Serve as the point of contact with regulatory agencies (e.g., FDA, EMA, MHRA, Health Canada), responding to inquiries and managing pre- and post-submission meetings.
• Ensure products, packaging, labeling, and advertising comply with regulatory requirements in all markets where the company operates.
• Work closely with R&D, Clinical, Quality, Legal, and Manufacturing teams to ensure alignment of regulatory requirements with business objectives.
• Develop internal SOPs, policies, and best practices for regulatory compliance and documentation control.
• Monitor, interpret, and communicate changes in regulatory requirements and industry standards; assess their impact on the company.
• Supervise and mentor junior regulatory staff; manage workload and deliverables for the regulatory affairs team.