VP, Global Regulatory Affairs & Strategy

Sagimet Biosciences Inc.; San Mateo (CA); On-site; USD 340,000 - 370,000; Full time

Job summary

Sagimet Biosciences Inc. seeks a Vice President of Regulatory and Head of Regulatory Affairs to shape global regulatory strategies and lead submissions to advance our clinical programs. This role will serve as the primary liaison with FDA, EMA and other agencies, collaborating with clinical, CMC and quality teams.

You will oversee INDs, NDAs/BLAs, maintain filings, manage vendors, and mentor a global regulatory organization while aligning plans with development timelines and business priorities.

Qualifications

• Advanced degree in a scientific or regulatory discipline.
• Minimum of 15 years of regulatory affairs experience in biotech/pharma.
• Proven IND, NDA/BLA submission success and approvals.

Responsibilities

• Develop and execute regulatory strategies to support clinical development.
• Lead preparation, submission and maintenance of regulatory filings.
• Collaborate with cross-functional teams and external advisors.

Skills

Regulatory expertise

US FDA regulations

Cross-functional leadership

Regulatory submissions

Communication skills

Education

PhD/PharmD/MD or equivalent

Tools

Regulatory submission software

Document management systems

Job description

Sagimet Biosciences Inc. seeks a Vice President of Regulatory and Head of Regulatory Affairs to shape global regulatory strategies and lead submissions to advance our clinical programs. This role will serve as the primary liaison with FDA, EMA and other agencies, collaborating with clinical, CMC and quality teams.

You will oversee INDs, NDAs/BLAs, maintain filings, manage vendors, and mentor a global regulatory organization while aligning plans with development timelines and business priorities.