Vice President, Regulatory and Head of Regulatory Affairs

Description

Position Summary:

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.

Essential Responsibilities:

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.

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 Skills:

• Experience working in a publicly traded biotech company.

The salary range for this position is $340,000-$370,000.

Actual compensation within this range will be based on the experience and qualifications of the selected candidate.