Regulatory and Public Affairs Manager

About the role

The Regulatory and Public Affairs Manager will lead the planning and execution of regulatory submissions for new and existing products, ensuring compliance with all applicable standards. This role also oversees public affairs activities, acting as a liaison with health agencies, licensors, and internal project teams.

Key responsibilities

• Develop and manage regulatory plans for product submissions and maintenance activities.
• Coordinate all regulatory activities throughout the product life‑cycle to guarantee timely and accurate submissions.
• Review submission dossiers, correspondence, labeling, and related documentation for quality and regulatory compliance.
• Monitor changes in regulations and guidance, informing project teams of potential impacts.
• Engage with health agencies and regulatory authorities to facilitate smooth approval processes.
• Provide regulatory input on agreements to ensure they meet regulatory standards.
• Prepare regulatory due‑diligence reports on potential product opportunities and recommend actions.
• Identify regulatory risks during due‑diligence and propose mitigation strategies.
• Lead communication with licensors to support due‑diligence activities.

Required profile

• Strong knowledge of regulatory requirements and guidance for healthcare products.
• Proven experience managing regulatory submissions and coordinating cross‑functional teams.
• Ability to assess regulatory risks and develop mitigation plans.
• Excellent communication skills for interacting with health agencies, licensors, and internal stakeholders.

Required skills