Director/Sr. Director, Regulatory

SAGIMET BIOSCIENCES INC. • San Mateo, CA

6h • $240,000 - $305,000

About The Position

Position Summary:

The Director/Senior Director, Regulatory, will lead and manage regulatory strategies and submissions to support clinical development and regulatory compliance for Sagimet. This role involves close collaboration with Sagimet’s cross-functional teams, external partners, and regulatory agencies to ensure the successful advancement of our clinical programs.

Requirements

• Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs).
• Minimum of 10 years of experience in regulatory affairs within the biotech or pharmaceutical industry.
• Proven track record of successful regulatory submissions, interactions, and approvals.
• Strong knowledge of regulatory requirements and guidelines (FDA, EMA, ICH, etc.).
• Excellent project management and organizational abilities and attention to detail.
• Exceptional communication and interpersonal skills.
• Ability to think strategically and provide regulatory insights.
• Strong problem-solving and decision-making capabilities.
• Proficiency in regulatory submission software and tools.
• Ability to manage advisors, consultants and regulatory vendors.

Nice To Haves

• Advanced degree (Master's, Ph.D., or Pharm.D.) preferred.
• Experience working in a publicly traded biotech company.
• Familiarity with clinical development processes and requirements.
• Demonstrated ability to manage complex, cross-functional projects with both internal and external stakeholders.
• Strong analytical skills and attention to detail.

Responsibilities

• 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.
• Lead the preparation, submission, and maintenance of regulatory filings, including INDs, NDAs, BLAs, and others.
• Ensure compliance with all applicable regulatory requirements and guidelines, including those issued by the FDA, EMA, and other global regulatory agencies.
• Work closely with clinical, R&D, quality, and other cross-functional teams to provide regulatory guidance and support throughout the product development lifecycle.
• Serve as the primary point of contact with regulatory agencies, managing communications, meetings, and negotiations to facilitate regulatory approvals.
• 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 potential regulatory risks and develop mitigation strategies to ensure program success.
• Stay current with regulatory trends, changes, and best practices, and provide strategic insights to the organization.
• Other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Director