Regulatory Strategy Leader — Global Submissions & Compliance

Regulatory Jobs; San Mateo (CA); On-site; USD 340,000 - 370,000; Full time

Job summary

Sagimet seeks a visionary VP of Regulatory Affairs to shape global regulatory strategy and lead submissions for INDs, NDAs, and MAAs. You will be the primary liaison with FDA, EMA, and other agencies, guiding cross-functional teams to secure timely approvals and ensure regulatory compliance.

You will manage external regulatory vendors, oversee submission quality, and monitor regulatory trends to inform clinical development decisions.

Qualifications

• Advanced degree in a scientific/regulatory discipline (Ph.D., PharmD, MD or equivalent).
• 15+ years regulatory affairs experience in biotech/pharma.
• Proven track record with IND/NDA/BLA submissions and approvals.

Responsibilities

• Develop and implement strategic regulatory plans for clinical development programs and ensure compliance.
• Lead regulatory submissions and maintain records for INDs, NDAs, BLAs, and MAAs.
• Coordinate cross-functional teams and external partners to support product development and regulatory strategy.
• Oversee regulatory vendor management and ensure high-quality submissions.

Skills

Regulatory strategy

FDA/EMA/regulatory knowledge

Cross-functional leadership

Regulatory submissions

Strategic communication

Vendor management

Regulatory software/tools

Education

Advanced degree (Ph.D./PharmD/MD) in regulatory/science

Tools

Regulatory submission software

Job description

Sagimet seeks a visionary VP of Regulatory Affairs to shape global regulatory strategy and lead submissions for INDs, NDAs, and MAAs. You will be the primary liaison with FDA, EMA, and other agencies, guiding cross-functional teams to secure timely approvals and ensure regulatory compliance.

You will manage external regulatory vendors, oversee submission quality, and monitor regulatory trends to inform clinical development decisions.