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

Role Summary

Senior Director, Global Regulatory CMC - Drug-Device Combination Products, serving as the enterprise regulatory leader for the global device and combination product portfolio. Responsible for defining and executing CMC regulatory strategy across development, licensure, commercialization, and lifecycle management. Collaborates with executive teams to shape regulatory posture, ensure patient supply continuity, and influence global regulatory policy. Hybrid/worksite options include 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.

Education

• Bachelor’s degree required; advanced degree preferred (science, engineering, law, or related fields).