Senior Director, Global Regulatory CMC- Drug- Device Combination Products
3 days ago• Flexible / Remote
About This Role:
As the Senior Director, Global Regulatory CMC - Drug-Device Combination Products, you will serve as the enterprise regulatory leader for our 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.
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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.
What You'll Do:
- 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.
Who You Are:
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.
Required Skills:
- 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.
Preferred Skills:
- Advanced degree in life sciences, engineering, biotechnology, law, or pharmaceutical sciences
- Experience with lifecycle management strategies and differentiated drug-device combination products.
#LI-Remote
Job Level: Management
Additional Information
The base compensation range for this role is: $241,000.00-$332,000.00
Base salary offered is determined through an analytical approach utilizing a combination of 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.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Client-provided location(s): Flexible / Remote
Job ID: Biogen-REQ22325
Employment Type: FULL_TIME
Posted: 2026-01-20T23:58:36
Perks and Benefits
Health and Wellness
- FSA
- HSA
- On-Site Gym
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Short-Term Disability
- Long-Term Disability
- Mental Health Benefits
- Fitness Subsidies
- HSA With Employer Contribution
Parental Benefits
- On-site/Nearby Childcare
- Fertility Benefits
- Adoption Assistance Program
- Family Support Resources
- Birth Parent or Maternity Leave
- Non-Birth Parent or Paternity Leave
- Adoption Leave
Work Flexibility
- Remote Work Opportunities
- Flexible Work Hours
- Hybrid Work Opportunities
Office Life and Perks
- Commuter Benefits Program
- Happy Hours
- Some Meals Provided
- Company Outings
- On-Site Cafeteria
- Holiday Events
Vacation and Time Off
- Leave of Absence
- Personal/Sick Days
- Paid Holidays
- Paid Vacation
- Sabbatical
- Volunteer Time Off
- Summer Fridays
Financial and Retirement
- Relocation Assistance
- Performance Bonus
- Company Equity
- 401(K) With Company Matching
- Stock Purchase Program
- Financial Counseling
Professional Development
- Promote From Within
- Access to Online Courses
- Lunch and Learns
- Tuition Reimbursement
- Internship Program
- Leadership Training Program
- Mentor Program
- Shadowing Opportunities
Diversity and Inclusion
- Diversity, Equity, and Inclusion Program
- Employee Resource Groups (ERG)