Senior Director, Regulatory CMC

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.