Director, Regulatory Affairs CMC, Combination Products and Device
About The Position
The Director, CMC Regulatory Affairs – Combination Products and Device is responsible for setting and leading global CMC regulatory strategy for complex, high-impact device and combination product portfolios, programs, or regulatory domains. This role serves as a strategic thought partner in strategy and execution, to shape development and lifecycle strategy, anticipate regulatory risk, and enable successful global registration and lifecycle management. The Director operates at a strategic level across PDM, Global Regulatory Affairs, Quality, and other cross-functional functions, guiding decisions where regulatory pathways may be complex, evolving, or without clear precedent, while ensuring alignment with business priorities and long-term capability building.
Requirements
- A scientific degree with extensive directly relevant experience in CMC, device or combination product development, and global regulatory affairs
- 12+ years with BA/ BS
- 10+ years with MA/ MS/ MBA
- 8+ years with PharmD/ PhD
- Significant experience defining and leading regulatory strategies for complex products, technologies, submissions, or regulatory domains
- Deep knowledge of global regulatory requirements, standards, and evolving expectations relevant to devices and combination products
- Demonstrated success influencing strategy and decision-making across senior cross-functional stakeholders in complex, matrixed environments
- Strong experience engaging with health authorities and shaping regulatory approaches for significant business and development milestones
- Demonstrated strategic acumen, sound judgment, and ability to lead through ambiguity and change
- Advanced communication, presentation, and leadership skills
Responsibilities
- Set and lead global CMC regulatory strategy for complex device and combination product portfolios, programs, or critical regulatory workstreams
- Shape global regulatory approaches that support product development, registration, lifecycle management, patient supply continuity, and long-term business objectives
- Serve as a strategic partner with cross-functional team by influencing key development, manufacturing, control strategy, and lifecycle decisions with a clear understanding of regulatory risk and opportunity
- Lead resolution of complex regulatory issues for combination product and device programs, including areas where regulations are evolving or where explicit precedent may be limited
- Guide development of regulatory risk mitigation and contingency strategies across major programs and submissions
- Oversee regulatory strategy and execution for major global submissions, significant post-approval changes, and other critical regulatory milestones (IND/CTA, NDA/BLA/MAA, Notified Body Opinion)
- Represent CMC Regulatory Affairs during health authority interactions on CMC topics relevant to combination products and device
- Drive consistent interpretation and implementation of global regulations, standards, and policy trends relevant to devices and combination products, and influence internal approaches accordingly
- Act as a bridge across global, regional, and functional stakeholders to ensure alignment, transparency, and execution against regulatory priorities
- Contribute to the strategic direction of combination product and device regulatory capability, including process improvements, knowledge sharing, talent development, and future-facing regulatory practices
- Participate in external industry forums, conferences, or policy-shaping discussions, as appropriate, to strengthen external insight and help inform Gilead’s regulatory position
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
- discretionary annual bonus
- discretionary stock-based long-term incentives
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
