Senior Manager, Regulatory Affairs

Job Summary

Leading the development and execution of regulatory strategies, the full-time Senior Manager, Regulatory Affairs will coordinate cross-functional teams to ensure compliance and support product approvals for biologic/combination products, while working remotely.

Key responsibilities

• Serve as the Global Regulatory Lead for hemostat and sealant products, ensuring alignment with regulatory requirements
• Provide technical and strategic input for regulatory decisions and manage complex projects to prioritize workload
• Act as the primary contact for regulatory authorities and mentor junior colleagues on US regulatory requirements

Required qualifications

• Bachelor's degree or equivalent in a scientific discipline; Master's or PhD preferred
• Minimum of 7 years of experience in Regulatory Affairs
• Expert knowledge of regulatory requirements and compliance
• Strong management skills with the ability to oversee multiple projects
• Experience in a multinational/multicultural environment