EPM Scientific
Director of Regulatory Affairs, CMC
EPM Scientific, San Diego, California, United States, 92189
Overview
Job Title: Director of Regulatory Affairs, CMC 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 Regulatory Affairs 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. Senior Leadership and Employment
Seniority level: Director Employment type: Full-time Location: San Diego Metropolitan Area Compensation: $280,000.00-$320,000.00
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Job Title: Director of Regulatory Affairs, CMC 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 Regulatory Affairs 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. Senior Leadership and Employment
Seniority level: Director Employment type: Full-time Location: San Diego Metropolitan Area Compensation: $280,000.00-$320,000.00
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