Director/Sr. Director, Regulatory at SAGIMET BIOSCIENCES INC.

San Mateo, California, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jun, 26

Salary

305000.0

Posted On

07 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategies, Regulatory Submissions, INDs, NDAs, BLAs, FDA Compliance, EMA Compliance, ICH Guidelines, Project Management, Communication, Strategic Thinking, Problem-Solving, Regulatory Risk Mitigation, Vendor Management, Clinical Development

Industry

Pharmaceutical Manufacturing

Description

Description 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. Essential 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. Education and Experience Requirements: Bachelor's degree in a relevant field (e.g., Life Sciences, Pharmacy, Regulatory Affairs). Advanced degree (Master's, Ph.D., or Pharm.D.) preferred. 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. Required Skills: 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. Preferred Skills: 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. Salary Range: Director = $240,000 - $265,000 Senior Director = $275,000 - $305,000 Actual compensation within this range will be based on the experience and qualifications of the selected candidate.

Responsibilities

The Director/Senior Director, Regulatory will lead and manage regulatory strategies and submissions to support clinical development and ensure regulatory compliance for Sagimet. This involves developing comprehensive strategies, leading filings (INDs, NDAs, BLAs), and serving as the primary contact with regulatory agencies.