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

About This Role

Senior Director, Global Regulatory CMC - Drug-Device Combination Products, serves as the enterprise regulatory leader for the global device and combination product portfolio. Operating within the Product Delivery Solutions team, you will have end-to-end accountability for defining and executing CMC regulatory strategy across development, licensure, commercialization, and lifecycle management. Your role is crucial in shaping the long-term regulatory posture for device-enabled therapies, ensuring patient supply continuity, and influencing global regulatory policy.

Reporting to the VP, Head of Product Delivery Solutions, you will be a core member of both the Product Delivery Solutions Leadership and Global Regulatory CMC Leadership Teams. Your leadership will directly impact patients by delivering differentiated regulatory outcomes.

The ideal candidate would work at one of our sites in Cambridge, MA or Research Triangle Park, NC in hybrid capacity, but willing to consider remote candidates as well.

• 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.

You are a strategic thinker with a deep understanding of global regulatory frameworks, especially in the context of drug-device combination products. Your leadership style is collaborative, and you excel at building and sustaining high-performing teams across global landscapes. You thrive in complex environments, adeptly navigating high-stakes regulatory landscapes while influencing broader enterprise strategies. Your ability to mentor and develop talent is matched by your commitment to continuous improvement and quality excellence.

• 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.
• Demonstrated regulatory leadership across Class II devices, In-Vitro Diagnostics, and Digital Health Solutions.
• Extensive experience leading global Health Authority engagements and negotiations.
• Proven ability to influence enterprise strategy, governance, and industry standards.
• Strong track record of building, scaling, and sustaining high-performing global teams.
• Expert knowledge of evolving regulatory expectations for device and combination product licensure.

• Advanced degree in life sciences, engineering, biotechnology, law, or pharmaceutical sciences
• Experience with lifecycle management strategies and differentiated drug-device combination products.

Note:

This role may be remote where permitted by the company’s policies.

The base compensation range for this role is: $-$. Base salary offered is determined through an analytical approach utilizing factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

Biogen offers a full and competitive…