Senior Director, Regulatory CMC

Jobgether; United States; Remote; USD 176,000 - 284,000; Full time

Benefits offered by this job

Executive compensation

Annual bonus opportunity

Comprehensive healthcare coverage

401(k) plan

Job summary

Jobgether is seeking a Senior Director, Regulatory CMC to lead global regulatory strategy for small-molecule programs from preclinical through NDA submissions. You will guide cross-functional teams on drug substance, product development, analytical methods, and manufacturing to ensure regulatory readiness.

This remote US-based role emphasizes strategic leadership, risk management, and external partner oversight.

Qualifications

• Master's degree required; PhD or PharmD preferred.
• At least 12 years of pharma industry experience with ≥5 years in Regulatory CMC.
• Experience leading NDA-enabling activities and marketing submissions.
• Proven ability to manage regulatory filings (INDs, NDAs, IMPDs, etc.).
• Health authority interactions and global regulatory strategy experience.
• Strong understanding of drug substance, product development, and QA with cGMP knowledge.
• Extensive external manufacturing/CDMO oversight and technology transfer experience.
• Experience across early development to lifecycle management; strong leadership.
• Excellent written and oral communication; cross‑functional influence.
• Preferred experience in orexin CNS or related areas; US remote work availability

Responsibilities

• Develop and execute integrated regulatory CMC strategies from preclinical through NDA submissions.
• Lead late-stage regulatory CMC activities and NDA-enabling work.
• Provide strategic guidance across substance, product, analytics, manufacturing and QA.
• Serve as the Regulatory CMC SME on program teams.
• Oversee preparation, review, and submission of CMC documentation for global filings.
• Engage with health authorities; respond to questions and feedback.
• Monitor global regulatory developments and adapt strategies accordingly.
• Manage CDMOs and external partners for tech transfer and scale‑up.
• Ensure compliance with cGMP and quality standards; readiness for inspections.
• Lead risk assessment, resource planning, and budget forecasting for CMC activities.

Skills

Regulatory leadership

Strategic thinking

Project management

Communication skills

Cross-functional collaboration

Risk management

Global regulatory knowledge

Education

Master's degree in Chemistry, Pharmaceutical Sciences, or related field

PhD or PharmD preferred

Job description

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.

We appreciate your interest and wish you the best!