Senior Director, Regulatory CMC

Job description

**This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Senior Director, Regulatory CMC based in the United States.** We are seeking an accomplished Senior Director, Regulatory CMC to lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy across a portfolio of small-molecule drug development programs. In this senior leadership role, you will guide regulatory activities from early development through late-stage clinical programs and marketing application submissions. You will serve as a strategic partner to cross-functional teams, ensuring that drug substance, drug product, analytical development, manufacturing, and quality strategies align with global regulatory expectations. You will play a critical role in preparing regulatory submissions, managing health authority interactions, and ensuring readiness for future commercialization. Working in a fast-paced, innovation-driven pharmaceutical environment, you will oversee external development and manufacturing partners while driving regulatory excellence, risk management, and operational execution. This remote opportunity is suited to a highly experienced regulatory professional with a strong track record in NDA-enabling activities and the ability to influence complex development decisions. ### Accountabilities - **Global Regulatory CMC Strategy:** Develop and execute integrated regulatory strategies for small-molecule programs, supporting development from preclinical stages through late-stage clinical development, marketing applications, and lifecycle management. - **Late-Stage Development and Registration:** Lead regulatory CMC activities for advanced development programs, including NDA-enabling work, marketing application preparation, and strategies to support successful product registration. - **Technical and Scientific Leadership:** Provide strategic guidance across drug substance, drug product, analytical development, manufacturing processes, specifications, and control strategies to ensure robust development and regulatory readiness. - **Cross-Functional Collaboration:** Serve as the Regulatory CMC subject matter expert on program teams, aligning CMC development plans with clinical, regulatory, quality, manufacturing, and business objectives. - **Regulatory Submission Management:** Lead the preparation, review, and approval of CMC documentation for global regulatory submissions, including INDs, CTAs, IMPDs, NDAs, supplements, variations, briefing packages, and responses to health authority questions. - **Health Authority Engagement:** Provide expert input into regulatory interactions, interpret agency feedback, and develop scientifically sound responses that support development milestones and registration objectives. - **Regulatory Intelligence:** Monitor evolving global regulatory requirements, FDA and EMA guidance, ICH standards, and relevant regulatory precedents, incorporating new insights into development and submission strategies. - **External Partner Management:** Oversee contract development and manufacturing organizations (CDMOs) and other external partners, including partner selection, performance management, technology transfer, process scale-up, validation, and manufacturing readiness. - **Quality and Compliance:** Ensure that development and manufacturing activities align with applicable global regulatory requirements, current Good Manufacturing Practices (cGMP), and relevant quality standards. - **Inspection and Supply Readiness:** Support regulatory inspection readiness and clinical supply continuity by identifying potential risks, strengthening documentation, and coordinating mitigation activities with internal and external stakeholders. - **Project and Resource Management:** Develop and manage project plans, timelines, budgets, forecasts, and risk mitigation strategies to ensure efficient execution of regulatory CMC activities. - **Risk Assessment and Decision Support:** Evaluate regulatory and technical risks, communicate potential impacts, and recommend practical solutions that balance scientific rigor, development timelines, and business objectives. - **Stakeholder and Partner Relationships:** Build effective working relationships across internal functions, external development organizations, manufacturing partners, and regulatory stakeholders to advance program goals. ## Requirements - **Education:** A master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline is required. A PhD or PharmD is preferred. - **Industry Experience:** At least 12 years of pharmaceutical industry experience, including a minimum of five years in Regulatory CMC roles supporting small-molecule development programs. - **Late-Stage Regulatory Leadership:** Recent, direct experience leading Regulatory CMC activities for late-stage development programs, including NDA-enabling activities and marketing application submissions, is required. - **Regulatory Submission Expertise:** Demonstrated experience authoring, reviewing, and managing CMC content for regulatory filings, including INDs, IMPDs, NDAs, and other global submissions. - **Health Authority Experience:** Proven ability to support regulatory interactions, prepare responses to agency questions, interpret regulatory feedback, and apply global regulatory expectations to development strategies. - **Small-Molecule Development Knowledge:** Strong understanding of drug substance and drug product development, analytical methods, pharmaceutical manufacturing processes, specifications, and control strategies. - **Global Regulatory Knowledge:** Thorough knowledge of FDA regulations, EMA requirements, ICH guidelines, cGMP expectations, and international Regulatory CMC principles. - **External Manufacturing Experience:** Extensive experience managing CDMOs and outsourced development and manufacturing activities, including technology transfer, process development, scale-up, validation, and clinical supply manufacturing. - **Early Development and Lifecycle Experience:** Experience supporting pharmaceutical programs from early development and IND submission through later-stage development, regulatory registration, and lifecycle management. - **Quality and Compliance Expertise:** Ability to assess manufacturing and quality risks, support inspection readiness, and ensure regulatory documentation meets applicable standards. - **Leadership and Strategic Thinking:** Strong strategic judgment and the ability to lead complex regulatory initiatives, influence cross-functional decisions, and anticipate challenges across development programs. - **Project Management:** Demonstrated ability to manage multiple priorities, coordinate stakeholders, oversee timelines and budgets, and deliver high-quality regulatory work in a dynamic environment. - **Communication and Collaboration:** Excellent written and verbal communication skills, with the ability to translate complex scientific and regulatory information into clear recommendations for technical and nontechnical audiences. - **Preferred Therapeutic Experience:** Experience in orexin biology, central nervous system (CNS) programs, or other specialized therapeutic areas is an advantage. - **Work Location and Travel:** Ability to work remotely from the United States and travel occasionally as required. ## Benefits - **Competitive Executive-Level Compensation:** Annual salary range of $175,500–$283,800, depending on qualifications, experience, skills, and geographic location. - **Annual Bonus Opportunity:** Eligibility for a company bonus based partly on organizational and individual performance. - **Retirement Savings:** Access to a company-sponsored 401(k) plan and pension benefits, subject to applicable eligibility requirements. - **Comprehensive Healthcare Coverage:** Medical, dental, vision, and prescription drug benefits for eligible employees. - **Flexible Spending Benefits:** Access to eligible healthcare and dependent-care spending programs. - **Insurance Protection:** Life insurance and death benefits, along with other applicable employee protection benefits. - **Paid Time Off:** Vacation benefits and eligible leave programs to support work-life balance. - **Employee Assistance and Wellbeing:** Access to an employee assistance program, fitness-related benefits, and employee clubs and activities. - **Remote Work Flexibility:** The opportunity to work remotely from the United States, with occasional travel as needed. - **Scientific and Professional Impact:** The opportunity to shape regulatory strategy across innovative small-molecule development programs and contribute to the advancement of potential new treatments. - **Cross-Functional Leadership:** Work closely with scientific, clinical, quality, manufacturing, and regulatory experts in a collaborative pharmaceutical development environment.