Director Regulatory Affairs

Director Regulatory Affairs - Metabolic, GLP-1

Location: Hybrid - SF or West Coast based preferred
Compensation: $180,000-230,000 annually + equity + bonus

About the Opportunity

Our client is a fast-growing biotech that's redefining metabolic health through GLP-1 and dual agonist therapies. Backed by strong funding and a robust pipeline, this company is entering pivotal stages of development and needs a Director of Regulatory Affairs to lead global strategy and execution.

This is a rare chance to join a team where your expertise will directly influence the success of first-in-class therapies for obesity and diabetes. If you thrive in a small, agile environment and want to make a measurable impact, this role is for you.

Key Responsibilities

• Develop and execute global regulatory strategies for clinical-stage programs.
• Lead IND, CTA, and NDA submissions and manage agency interactions.
• Serve as the primary regulatory contact for FDA and ex-US authorities.
• Collaborate cross-functionally with clinical, CMC, and quality teams to ensure compliance and readiness.
• Anticipate regulatory risks and implement proactive solutions.

Ideal Profile

• 8+ years in regulatory affairs, with experience in metabolic or endocrine indications.
• Proven success in leading submissions and regulatory meetings.
• Comfortable in a dynamic, small-company setting-hands-on and strategic.
• Strong communication and relationship-building skills.

Why This Role Stands Out

• Innovative Science: Work on oral GLP-1 and next-gen metabolic therapies.
• Impact: Your leadership will accelerate programs that could transform care for millions.
• Flexibility: Hybrid role
• Competitive Package: Fair, market-aligned salary, equity, and comprehensive benefits.

Interested in learning more? Apply confidentially and if you are a good fit, we will reach out to discuss further.