Executive Director – Regulatory Affairs, Combination Products & Devices
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Job Description
Executive Director overseeing global regulatory strategies for combination products and devices at Gilead. Fostering collaboration across functions to ensure regulatory excellence and compliance.
Responsibilities:
- Define and drive global regulatory strategies for combination products
- Champion regulatory innovation and novel approaches to accelerate development
- Lead the development of global CMC regulatory initiatives focused on combination products
- Cultivate strong, collaborative relationships across Gilead’s global functions
- Provide strategic direction and oversight for late-stage development programs
- Oversee the drafting, review, and approval of CMC sections for regulatory filings
- Provide leadership for agency interactions, inspections, and regulatory responses
- Ensure readiness and compliance for global commercialization
- Provide strategic input to Design Control processes and documentation
- Foster a culture of integrity, excellence, and continuous improvement within the global CMC RA organization
Requirements:
- A scientific degree with directly relevant professional experience in small molecule and biologics development
- Global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD
- Demonstrated track record in leading CMC regulatory affairs initiatives
- Innovative CMC regulatory strategies
- Experience leading NDA/BLA submission and approvals including global Health Authority Interactions
- Excellent strategic acumen, collaboration, and communication skills are required
- In-depth understanding of ICH guidelines and GMP requirements for development and manufacturing of small molecules and biologics
- Proven track record in the successful development and commercialization of device technologies
- Demonstrated organizational leadership skills at both functional and enterprise levels.
Benefits:
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans
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