New · posted Oct 15
Sagimet Biosciences · Biotechnology
Vice President, Regulatory and Head of Regulatory Affairs
- San Mateo, CA
- On-site
- Full-time
- VP & Executive
Open until filled
The role
The VP of Regulatory and Head of Regulatory Affairs will shape and execute regulatory strategies and lead and manage submissions to support clinical development and regulatory compliance for Sagimet. This role will serve as the primary liaison with global regulatory authorities and involve close collaboration with Sagimet’s cross-functional teams and external partners, to ensure the successful advancement of our clinical programs.
Description
What you need
Education and Experience Requirements
- Advanced degree (Ph.D., PharmD, MD, or equivalent preferred) in a scientific or regulatory discipline.
- Minimum of 15 years of experience in regulatory affairs within the biotech or pharmaceutical industry.
- Proven track record of successful IND, NDA/BLA submissions, interactions, and approvals.
Required Skills
- Deep expertise in US and international regulatory systems (FDA, EMA, NMPA, PMDA) and familiarity with clinical development processes and requirements
- Demonstrated ability to manage complex, cross-functional projects with both internal and external stakeholders and regulatory vendors
- Exceptional communication and interpersonal skills with the ability to think strategically and provide regulatory insights.
- Strong problem-solving and decision-making capabilities and attention to detail.
- Proficiency in regulatory submission software and tools.
Preferred Skillsnice to have
- Experience working in a publicly traded biotech company.
Actual compensation within this range will be based on the experience and qualifications of the selected candidate.
What you'll do
Strategic Leadership & Planning
- Develop and implement comprehensive regulatory strategies to support the Company’s clinical development programs and ensure compliance with regulatory requirements applicable to our clinical development activities.
- Align regulatory plans with product lifecycle, commercial objectives, and business priorities.
- Monitor global regulatory trends, guidance updates, and agency priorities to adapt strategies proactively and provide strategic insights to the organization.
Regulatory Submissions & Filings
- Lead the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, MAAs, briefing books, CTAs, DSURs, IBs, and others.
- Ensure compliance with all applicable regulatory requirements and guidelines, including those issued by the FDA, EMA, and other global regulatory agencies
- Serve as the primary point of contact with regulatory agencies, managing communications, meetings, and negotiations to facilitate regulatory approvals.
- Ensure submissions meet highest quality standards and are submitted on schedule.
- Oversee electronic submission vendor management and maintain accurate submission records.
Cross-Functional Collaboration
- Partner with clinical development and operations, R&D, quality, and other cross-functional teams to provide regulatory guidance and support throughout the product development lifecycle.
- Oversee the company’s external regulatory advisors, consultants and vendors to ensure that relevant regulatory advice is provided with respect to the company’s development programs.
- Identify and communicate potential regulatory risks and develop mitigation strategies to ensure program success.
Pay
$340,000 – $370,000 a year
Employer providedThe salary range for this position is $340,000-$370,000.
Where you'll work
San Mateo, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in San Mateo, CAJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 11% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
VP & Executive roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $340,000 | — | $370,000 |
| All US (middle half) | $305,750 | $320,500 | $362,250 |
This role: Sagimet Biosciences's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 290 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Sagimet Biosciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions7
- Collaboration and leadership7
- GMP and compliance3
- Documentation and SOPs2
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Sagimet Biosciences on Regulatory Jobs
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- Open roles
- 2
- Distinct roles
- 2
- Locations
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Vice President, Regulatory and Head of Regulatory Affairs at Sagimet Biosciences
Open until filled. $340K–$370K a year, employer provided.