Sr Manager, Regulatory Affairs CMC, Combination Products and Device
Gilead Sciences
August 11, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Senior Manager, CMC Regulatory Affairs – Combination Products and Device
Key Responsibilities
- Develop and implement global CMC regulatory strategies for combination product development, registration, and lifecycle management.
- Serve as CMC Regulatory Affairs Combination Product and Device Lead for assigned programs/workstreams.
- Interpret and apply regulations/guidance for devices and combination products; provide regulatory input for device-related development, control strategy, design control documentation, and lifecycle changes.
- Prepare and support submission of high-quality CMC content (IND/CTA, NDA/BLA/MAA, Notified Body Opinion; investigational, marketing, and post-approval).
- Partner cross-functionally for submission readiness, timeline execution, and resolution/escalation of CMC regulatory risks and issues.
- Support health authority interactions (background packages, agency responses, follow-up).
- Conduct regulatory impact assessments and maintain awareness of regulatory trends.
- Contribute to priority policy/trade organization working groups and to process improvement/operational excellence.
Qualifications
- Undergraduate or advanced degree in life sciences (or related) with significant CMC/manufacturing/device/development/regulatory experience.
- Experience: leading routine to moderately complex CMC regulatory activities for regulatory filings.
- Working knowledge of global CMC requirements for devices/combination products.
Required/Preferred Skills
- Ability to translate technical information into regulatory actions/plans.
- Strong collaboration, organizational, project management, and verbal/written/presentation skills.
- Ability to influence cross-functionally without direct authority.
Benefits/Application Instructions (as stated)
- Salary range: $157,590.00–$203,940.00; may be eligible for discretionary bonus/long-term incentives, paid time off, and medical/dental/vision/life insurance.
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.
Key Responsibilities
- Develop and implement global CMC regulatory strategies for combination product development, registration, and lifecycle management.
- Serve as CMC Regulatory Affairs Combination Product and Device Lead for assigned programs/workstreams.
- Interpret and apply regulations/guidance for devices and combination products; provide regulatory input for device-related development, control strategy, design control documentation, and lifecycle changes.
- Prepare and support submission of high-quality CMC content (IND/CTA, NDA/BLA/MAA, Notified Body Opinion; investigational, marketing, and post-approval).
- Partner cross-functionally for submission readiness, timeline execution, and resolution/escalation of CMC regulatory risks and issues.
- Support health authority interactions (background packages, agency responses, follow-up).
- Conduct regulatory impact assessments and maintain awareness of regulatory trends.
- Contribute to priority policy/trade organization working groups and to process improvement/operational excellence.
Qualifications
- Undergraduate or advanced degree in life sciences (or related) with significant CMC/manufacturing/device/development/regulatory experience.
- Experience: leading routine to moderately complex CMC regulatory activities for regulatory filings.
- Working knowledge of global CMC requirements for devices/combination products.
Required/Preferred Skills
- Ability to translate technical information into regulatory actions/plans.
- Strong collaboration, organizational, project management, and verbal/written/presentation skills.
- Ability to influence cross-functionally without direct authority.
Benefits/Application Instructions (as stated)
- Salary range: $157,590.00–$203,940.00; may be eligible for discretionary bonus/long-term incentives, paid time off, and medical/dental/vision/life insurance.
- For current employees/contractors: apply via the Internal Career Opportunities portal in Workday.