Director​/Sr. Director, Regulatory CMC

• Develop and implement comprehensive global regulatory CMC strategies for assigned gene therapy programs, including IND/CTA, BLA/MAA, and post-approval submissions
• Lead and manage the preparation, authoring, and review of high-quality CMC sections for all regulatory submissions, ensuring scientific accuracy, clarity, and adherence to regulatory guidelines
• Act as the primary regulatory CMC liaison with health authorities (e.g., FDA, EMA, PMDA) for assigned gene therapy projects, leading and facilitating interactions, teleconferences, and meetings
• Provide expert regulatory CMC guidance and support to cross-functional development teams (e.g., R&D, Manufacturing, Quality, Clinical) throughout the product lifecycle
• Proactively identify and assess regulatory CMC risks and opportunities, developing mitigation strategies and providing strategic recommendations to senior leadership
• Stay current with evolving global regulatory requirements, guidelines, and industry best practices pertaining to gene therapies and advanced therapeutic medicinal products (ATMPs)
• Lead and mentor junior regulatory CMC professionals, encouraging a culture of excellence and continuous improvement
• Contribute to the development and improvement of internal regulatory CMC processes, standards, and templates
• Manage external consultants and contractors as needed to support regulatory CMC activities

• Bachelor's degree in a scientific discipline (e.g., Biochemistry, Molecular Biology, Chemistry, Pharmacy, Chemical Engineering) is required
• 5+ years of expertise in regulatory CMC for gene therapy, cell therapy, or other advanced therapeutic medicinal products (ATMPs)
• 5+ years of experience with global regulatory submissions (e.g., IND/CTA, BLA/MAA) and interactions with major health authorities (FDA, EMA, etc.)
• In-depth knowledge of global regulatory requirements and guidelines for biologics and ATMPs (e.g., ICH, FDA, EMA)
• Strong scientific understanding of gene therapy technologies, manufacturing processes, and analytical methods
• Proven leadership and interpersonal skills, with the ability to influence and collaborate effectively with diverse cross-functional teams and external stakeholders
• Ability to manage multiple projects simultaneously in a fast-paced and dynamic environment
• Proficiency in regulatory information management systems and Microsoft Office Suite.

Expertise in developing and implementing global regulatory CMC strategies for gene therapy programs, with a strong focus on regulatory submissions and compliance. Proven ability to lead cross-functional teams and mentor junior professionals while managing regulatory risks and opportunities.

• Regulatory CMC Expertise
• Global Regulatory Submissions
• Gene Therapy Knowledge
• Leadership Skills
• Regulatory Information Management

• Regulatory CMC Strategy Development
• IND/CTA Submission
• BLA/MAA Submission
• Regulatory Guidelines Adherence
• Scientific Accuracy in Documentation
• Analytical Methods Understanding
• Manufacturing Process Knowledge
• Risk Assessment and Mitigation
• Cross-Functional Team Collaboration
• Continuous Improvement Processes

• Interpersonal Skills
• Influencing Skills
• Project Management
• Mentoring Skills
• Collaboration Skills

• Gene Therapy
• Advanced Therapeutic Medicinal Products (ATMPs)
• Biologics
• FDA
• EMA
• ICH
• Health Authorities
• Regulatory Submissions
• Post-Approval Submissions
• Cross-Functional Development Teams

• Regulatory Information Management Systems
• Microsoft Office Suite