Sr Manager, Regulatory Affairs CMC
Gilead Sciences
July 02, 2026
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Senior Manager, CMC Regulatory Affairs (Biologics) — Responsibilities:
- Act as CMC regulatory lead for one or more products.
- Prepare and submit complex regulatory documents for investigational and commercial products, coordinating with departments outside CMC Regulatory Affairs, in line with ICH requirements, regional requirements, and scientific/company policies. Examples: safety reports, amendments, supplements, license renewals, original INDs/CTAs, and NDAs/MAAs.
- Contribute to regulatory strategy and solutions for CMC challenges for clinical/commercial projects.
- Interpret and implement ICH and other global guidelines to enable an approved/harmonized regulatory control strategy.
- Partner across CMC Regulatory Affairs, PDM, and other functional groups.
- Model and demonstrate Core Values, Leadership Commitments, and People Leader accountabilities; comply with global CMC principles of integrity.
Qualifications:
- Undergraduate or advanced degree in life sciences (or related) with significant CMC/manufacturing/research/development/regulatory experience in biopharma; at least 8 years with BA/BS, 6 years with MA/MS/MBA, or 2 years with PhD/PharmD.
- Significant experience supporting development and managing submissions of regulatory filings; proven ability to independently complete routine regulatory submissions.
- In-depth knowledge of the global CMC regulatory landscape.
- Ability to develop/implement regulatory strategy and lead small teams.
- Excellent collaboration/organizational skills and ability to manage multiple projects with tight timelines.
- Strong verbal, written, and presentation skills.
Benefits (explicitly stated):
- Company-sponsored medical, dental, vision, and life insurance.
Application instructions:
- Please apply via the Internal Career Opportunities portal in Workday.
- Act as CMC regulatory lead for one or more products.
- Prepare and submit complex regulatory documents for investigational and commercial products, coordinating with departments outside CMC Regulatory Affairs, in line with ICH requirements, regional requirements, and scientific/company policies. Examples: safety reports, amendments, supplements, license renewals, original INDs/CTAs, and NDAs/MAAs.
- Contribute to regulatory strategy and solutions for CMC challenges for clinical/commercial projects.
- Interpret and implement ICH and other global guidelines to enable an approved/harmonized regulatory control strategy.
- Partner across CMC Regulatory Affairs, PDM, and other functional groups.
- Model and demonstrate Core Values, Leadership Commitments, and People Leader accountabilities; comply with global CMC principles of integrity.
Qualifications:
- Undergraduate or advanced degree in life sciences (or related) with significant CMC/manufacturing/research/development/regulatory experience in biopharma; at least 8 years with BA/BS, 6 years with MA/MS/MBA, or 2 years with PhD/PharmD.
- Significant experience supporting development and managing submissions of regulatory filings; proven ability to independently complete routine regulatory submissions.
- In-depth knowledge of the global CMC regulatory landscape.
- Ability to develop/implement regulatory strategy and lead small teams.
- Excellent collaboration/organizational skills and ability to manage multiple projects with tight timelines.
- Strong verbal, written, and presentation skills.
Benefits (explicitly stated):
- Company-sponsored medical, dental, vision, and life insurance.
Application instructions:
- Please apply via the Internal Career Opportunities portal in Workday.