Job Description

Job Title: Director of Regulatory Affairs, CMC

Location: San Diego, CA (on-site | full time)

Company: [Confidential Biotech Company]

Lead the Regulatory Strategy Behind Tomorrow's Therapies

About the Company: This is a rare opportunity to join a dynamic, clinical-stage biotech focused on advancing small molecule treatments that could reshape patient care. As Director of Regulatory Affairs - CMC, you'll be the strategic force behind global filings, guiding products from early development through pivotal milestones and toward commercial success.

Position Overview: The company is seeking a highly motivated and experienced Director or Senior Director of Analytical Development to join their team. This is a unique opportunity to lead analytical development efforts, particularly focusing on adeno-associated virus (AAV) vectors, and make a significant impact on their mission to transform heart disease treatment.

Why Join the Company?

• Impact at Every Stage: You'll lead regulatory CMC strategy for investigational and marketed products, influencing everything from INDs to global marketing applications.
• Cross-Functional Leadership: Partner with Manufacturing, Quality, R&D, and external collaborators to ensure alignment and execution across the development lifecycle.
• Global Perspective: Drive regulatory activities across US and international markets, helping shape submissions that meet diverse global standards.
• Mission-Driven Work: Your decisions will directly accelerate access to therapies that matter-bringing hope to patients worldwide.

What You Bring to the Table

• 8+ years of experience in Regulatory CMC, with a strong foundation in small molecule development
• Proven success in preparing and submitting CMC sections of INDs, CTAs, NDAs, and MAAs
• Deep understanding of global regulatory frameworks and evolving guidelines
• Ability to lead in a fast-paced, collaborative environment with shifting priorities
• Strategic mindset with a hands-on approach to problem-solving and execution

What You'll Be Responsible For

• Develop and implement global CMC regulatory strategies across the product portfolio
• Lead regulatory planning and execution to support clinical trials and marketing approvals
• Serve as the regulatory lead on CMC development teams, providing guidance and oversight
• Interface with health authorities and external partners to ensure alignment and compliance
• Monitor regulatory trends and assess their impact on current and future programs

What You'll Gain

• Strategic Ownership: Your leadership will shape timelines, submissions, and regulatory success.
• Visibility & Influence: Work closely with senior leadership and cross-functional teams-your voice will be heard.
• Competitive Rewards: Strong base salary, performance-based bonus, and equity participation.
• Comprehensive Benefits: Medical, dental, vision, 401(k) match, stock purchase plan, generous PTO, paid parental leave, tuition assistance, and more.
• Inclusive Culture: Join a team that values diversity, innovation, and collaboration-where your perspective drives progress.

This is more than a job-it's a chance to lead with purpose and shape the future of medicine.

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