Senior Director, Global Regulatory CMC – Drug-Device Combination Products
Biogen
full-time
Posted on:
Location Type: Hybrid
Location: Remote • Massachusetts • North Carolina • United States
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Salary
💰 $241,000 - $332,000 per year
Job Level
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyCMC regulatory submissionsquality systems oversightchange controldeviation managementregulatory leadershipClass II devicesIn-Vitro DiagnosticsDigital Health Solutionsglobal Health Authority engagements
Soft Skills
mentoringstrategic thinkingaccountabilityinfluencingteam buildingscaling teamsnegotiationexecutive leadership
Certifications
Bachelor's degree