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

at Biogen

• Job title: Senior Director, Global Regulatory CMC – Drug-Device Combination Products
• Job type: Full Time
• Experience level: Senior
• Salary: $241,000 - $332,000 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Remote, United States

About the role

• Senior Director overseeing global regulatory CMC strategy for drug-device combination products and medical devices. Leading regulatory strategy development and ensuring compliance across regions.

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.

Requirements

• 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.

Benefits

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation