Senior Director, Global Regulatory CMC- Drug- Device Combination Products

Role Summary

Senior regulatory leader responsible for defining and executing global CMC strategy for drug-device combination products, diagnostics, and medical devices. Leads end-to-end regulatory activities across development, licensure, commercialization, and lifecycle management, shaping the regulatory posture for device-enabled therapies and influencing global policy. hybrid work options in Cambridge, MA or Research Triangle Park, NC with consideration for remote candidates.

Responsibilities

• Define and own the global regulatory CMC strategy for drug-device combination products, diagnostics, and medical devices.
• Serve as the primary regulatory authority for complex, high-risk programs for all non-implantable device programs.
• Lead global regulatory strategy development and execution across development, registration, commercialization, and lifecycle management.
• Ensure quality, consistency, and timeliness of global CMC regulatory submissions across all regions.
• Act as the senior regulatory representative with global Health Authorities for device and combination product portfolios.
• Mentor and develop senior leaders and regulatory experts, fostering a culture of accountability and strategic thinking.
• Provide executive regulatory leadership for quality systems oversight, including change control and deviation management.
• Standardize processes and embed best practices to improve efficiency and scalability.
• Represent Biogen in external industry forums and influence regulatory standards and paradigms.

Qualifications

• Required: Bachelor’s degree and 15+ years of industry experience in Medical Device and Combination Product Regulatory Affairs with at least 10 years of experience leading global regulatory organizations within pharmaceutical or biotechnology environments.
• Required: Demonstrated regulatory leadership across Class II devices, In-Vitro Diagnostics, and Digital Health Solutions.
• Required: Extensive experience leading global Health Authority engagements and negotiations.
• Required: Proven ability to influence enterprise strategy, governance, and industry standards.
• Required: Strong track record of building, scaling, and sustaining high-performing global teams.
• Required: Expert knowledge of evolving regulatory expectations for device and combination product licensure.
• Preferred: Advanced degree in life sciences, engineering, biotechnology, law, or pharmaceutical sciences.
• Preferred: Experience with lifecycle management strategies and differentiated drug-device combination products.