Sr Manager, Regulatory Affairs CMC
Gilead Sciences
18 days ago
Remote friendly (San Francisco Bay Area)
United States
Corporate Functions
Senior Manager, CMC Regulatory Affairs for Biologics
Responsibilities:
- Serve as CMC regulatory lead for a single or multiple products.
- Prepare and submit complex regulatory documents requiring cross-department interaction for investigational and commercial products (e.g., safety reports, amendments, supplements, license renewals for clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories).
- Contribute to regulatory strategy and solutions for CMC challenges for clinical or commercial projects.
- Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy.
- Partner across CMC Regulatory Affairs, PDM, and other functional groups.
Qualifications:
- Undergraduate or advanced degree in life sciences (or related field) with significant CMC/manufacturing/research/development/regulatory experience in biopharma; minimum experience: 8 years with BA/BS, 6 years with MA/MS/MBA, or 2 years with PhD/PharmD.
- Significant experience managing life-sciences regulatory filings, including independent completion of routine submissions.
- In-depth knowledge of global CMC regulatory landscape.
- Ability to develop/implement regulatory strategy and lead small teams.
- Excellent collaboration/organizational skills; strong verbal/written communication and presentation skills.
Benefits/Compensation (as stated): $157,590.00–$203,940.00 salary range; may be eligible for bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.
Responsibilities:
- Serve as CMC regulatory lead for a single or multiple products.
- Prepare and submit complex regulatory documents requiring cross-department interaction for investigational and commercial products (e.g., safety reports, amendments, supplements, license renewals for clinical trial applications and marketing authorizations, and original INDs/CTAs and NDAs/MAAs for assigned territories).
- Contribute to regulatory strategy and solutions for CMC challenges for clinical or commercial projects.
- Interpret and implement ICH and other global guidelines to achieve an approved/harmonized regulatory control strategy.
- Partner across CMC Regulatory Affairs, PDM, and other functional groups.
Qualifications:
- Undergraduate or advanced degree in life sciences (or related field) with significant CMC/manufacturing/research/development/regulatory experience in biopharma; minimum experience: 8 years with BA/BS, 6 years with MA/MS/MBA, or 2 years with PhD/PharmD.
- Significant experience managing life-sciences regulatory filings, including independent completion of routine submissions.
- In-depth knowledge of global CMC regulatory landscape.
- Ability to develop/implement regulatory strategy and lead small teams.
- Excellent collaboration/organizational skills; strong verbal/written communication and presentation skills.
Benefits/Compensation (as stated): $157,590.00–$203,940.00 salary range; may be eligible for bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life insurance.
Application instructions: For current Gilead employees/contractors, apply via the Internal Career Opportunities portal in Workday.