Senior Director, Regulatory Affairs, 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 Affairs, CMC based in the United States. As Senior Director, Regulatory Affairs, CMC, you will lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategy for an innovative oncology portfolio, with a particular focus on antibody-drug conjugates (ADCs). You will serve as the Global Regulatory Lead for a late-stage program progressing toward Biologics License Application (BLA) submission, overseeing regulatory planning, execution, and health authority interactions. This strategic leadership role combines scientific expertise, regulatory excellence, and people management to advance complex therapies through development, registration, commercialization, and lifecycle management. You will lead a U.S.-based team while coordinating with global, cross-functional stakeholders across manufacturing, quality, supply chain, clinical development, and regulatory affairs. By anticipating regulatory risks and ensuring high-quality submissions, you will help accelerate development timelines and maintain compliance across a dynamic product portfolio. This is an opportunity to influence global regulatory strategy and contribute to making innovative cancer treatments more accessible to patients worldwide. \n Accountabilities

* Lead Regulatory CMC strategy: Direct the development and execution of global CMC regulatory strategies for the ADC portfolio throughout development, registration, commercialization, and lifecycle management. * Oversee global regulatory leadership: Serve as the Global Regulatory Lead for a late-stage ADC program approaching BLA submission, coordinating regional regulatory team members and ensuring alignment on global strategy, priorities, and deliverables. * Manage regulatory submissions: Lead the preparation, review, finalization, and maintenance of CMC regulatory dossiers, ensuring submissions and responses meet applicable regulatory requirements and established timelines. * Coordinate health authority interactions: Lead regulatory engagement and responses to health authority questions, ensuring clear, scientifically sound, and strategically aligned communications. * Build and develop the team: Lead and mentor a U.S.-based Regulatory CMC team of approximately five professionals, fostering technical excellence, accountability, collaboration, and professional development. * Drive cross-functional collaboration: Partner with CMC, Manufacturing, Quality, Supply Chain, Clinical, and Global Regulatory Affairs teams to align regulatory strategies with product development plans and business objectives. * Manage regulatory changes: Oversee CMC change-control impact assessments and determine appropriate regulatory pathways, filing requirements, and implementation timelines. * Identify and mitigate regulatory risks: Proactively assess regulatory risks across the ADC portfolio, develop mitigation plans, and escalate significant issues to senior leadership when necessary. * Maintain regulatory compliance: Establish and continuously improve standard operating procedures, work instructions, and best practices to promote consistency, compliance, and inspection readiness. * Support product quality and lifecycle management: Guide regulatory assessments and strategies related to product quality issues, deviations, complaints, recalls, and other post-approval or lifecycle matters. * Review and approve documentation: Ensure the quality, accuracy, and regulatory compliance of CMC submissions, responses, internal procedures, and relevant records maintained in the Regulatory Information Management (RIM) system. * Support business development: Lead or oversee Regulatory CMC due diligence for licensing, acquisitions, and other strategic opportunities, identifying regulatory gaps, risks, and potential impacts. * Represent the regulatory function externally: Participate in industry forums, scientific conferences, and regulatory discussions to contribute expertise and maintain awareness of evolving requirements. * Drive continuous improvement: Promote knowledge sharing, technical innovation, and consistent regulatory practices while strengthening collaboration across global project teams.

Requirements

* Education: Bachelor's degree in a scientific discipline required; a master's degree or PhD is preferred. * Industry experience: At least 12 years of relevant pharmaceutical or biotechnology industry experience, including substantial experience in Regulatory CMC. * ADC regulatory expertise: Demonstrated experience leading one or more antibody-drug conjugate programs through development milestones, ideally from Investigational New Drug (IND) submission through BLA or Marketing Authorization Application (MAA) and health authority interactions. * Global regulatory leadership: Proven ability to establish and execute global CMC regulatory strategies, coordinate regional regulatory activities, and lead complex regulatory programs toward major submission milestones. * Submission and health authority experience: Strong experience with CMC dossier preparation, regulatory submission management, agency interactions, and product lifecycle maintenance. * Technical and scientific knowledge: In-depth understanding of CMC development, manufacturing processes, product quality, regulatory change control, and applicable pharmaceutical regulations and guidelines. * Risk management and compliance: Demonstrated ability to assess regulatory risks, develop mitigation strategies, maintain compliance, and ensure readiness for inspections and regulatory reviews. * People management: Experience leading, coaching, and developing technical professionals, with the ability to establish clear expectations, encourage accountability, and build a high-performing team. * Matrix leadership: Ability to lead global, cross-functional project teams and influence stakeholders across scientific, technical, operational, and regulatory functions without relying solely on direct reporting relationships. * Strategic and analytical thinking: Strong judgment and problem-solving skills, with the ability to evaluate complex regulatory issues, anticipate challenges, and translate technical information into actionable decisions. * Communication and stakeholder management: Excellent written, verbal, and presentation skills, including the ability to communicate complex scientific and regulatory concepts clearly to senior leaders and multidisciplinary teams. * Collaboration and adaptability: Demonstrated ability to foster teamwork, provide and receive constructive feedback, embrace change, take initiative, and maintain a results-oriented approach in a global, culturally diverse environment. * Continuous improvement: Commitment to technical excellence, ongoing learning, innovation, and the development of consistent regulatory standards and best practices. * Business and financial awareness: Ability to balance regulatory requirements, product development priorities, operational considerations, and broader business objectives.

Benefits

* Competitive base salary: Annual compensation ranging from $204,500 to $274,500, depending on qualifications, experience, skills, and work location. * Annual bonus opportunity: Eligibility to participate in an annual bonus plan for non-commercial roles. * Equity opportunities: Eligibility for discretionary equity awards and voluntary participation in an Employee Stock Purchase Plan. * Comprehensive healthcare: Medical, dental, and vision insurance. * Retirement savings: Access to a 401(k) retirement plan. * Flexible spending and savings accounts: Health Savings Account (HSA) and Flexible Spending Account (FSA) options. * Insurance protection: Life insurance coverage. * Paid time off: Paid leave to support personal needs, rest, and work-life balance. * Wellness benefits: Programs and resources designed to support employee well-being. * Remote work: Full-time remote opportunity based in the United States. * Professional growth: Opportunities to lead a global regulatory portfolio, develop a technical team, and contribute to high-impact oncology programs. * Collaborative global environment: Work with multidisciplinary experts across international teams, supporting scientific innovation and regulatory excellence. * Meaningful impact: Contribute to advancing innovative cancer therapies through development and regulatory approval, helping improve access to treatment for patients worldwide.

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