The Opportunity:

The Director, CMC Regulatory is responsible for developing, driving, and executing CMC regulatory strategies for products advancing through clinical development and marketing authorization. This role combines strategic leadership with hands-on submission delivery to support global clinical trial applications, registration, commercial readiness, and lifecycle management.

Responsibilities:

• Serve as the CMC Regulatory program lead to develop and execute global CMC regulatory strategies from clinical development through marketing authorization and lifecycle management, aligning regulatory activities and submission plans with program milestones and business objectives.

• Lead the preparation, review, and maintenance of scientifically sound, high-quality global CMC dossiers across all development stages, ensuring compliance with applicable regulatory requirements and timely submissions.

• Participate in CMC-related Health Authority interactions, including developing meeting strategies, preparing briefing documents, and responding to Agency queries. Collaborate with CMC and Quality teams to support inspection readiness and fulfill regulatory commitments.

• Support post-approval CMC regulatory activities, including assessing CMC changes, determining reporting requirements and supporting data needs, and developing and executing submission strategies.

• Provide CMC regulatory assessments for change controls, deviations, and investigations, and track regulatory commitments and submission obligations.

• Collaborate with Regulatory Affairs colleagues, technical SMEs, and external partners to address regional requirements, support regulatory submissions, and maintain consistency of approved CMC content.

• Mentor team members, provide guidance to regulatory resources, and contribute to improving CMC regulatory processes and submission standards.

Required Skills, Experience and Education:

• Bachelor’s degree in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related scientific discipline.

• Minimum of 15 years of experience in pharmaceutical/biotech drug development, including at least 5 years of hands-on global CMC regulatory affairs experience.

• Deep expertise in CMC development for new chemical entities (NCEs), with proven ability to manage complex technical content.

• Experience in leading CMC-related global submissions (IND, IMPD/CTA, NDA, MAA, post approval variations, etc.).

• Strong knowledge of US and international GMP regulations, current industry practices, with a demonstrated ability to interpret and apply requirements across the entire product lifecycle.

• Strong project and team leadership capabilities, with the ability to prioritize effectively, manage multiple complex programs, and foster cross-functional collaboration.

• Effective written and verbal communication skills and interpersonal skills.

• A collaborative, high-energy team player who thrives in a fast-paced, dynamic environment and embraces innovation and continuous improvement.

Preferred Skills:

• Advanced degree (MS or Ph.D) in Pharmaceutical Science, Chemistry, Chemical Engineering, or closely related field.

• Prior experience in oncology product commercialization is a plus.

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