Director, CMC, Regulatory Affairs

Role Summary

Director, CMC Regulatory Affairs to support a novel rare disease CNS pipeline. Will provide regulatory strategy support to the Regulatory Affairs (CMC) Team and CMC/Manufacturing Teams at the gene therapy facility to plan and execute regulatory activities that align with short- and long-term company objectives. A team player with a roll-up-sleeves attitude and subject matter expertise in CMC, contributing to the shift from clinical development to commercialization.

Responsibilities

• Provide CMC regulatory input to cross-functional teams, including Technical Operations, Process Development, Quality, and Clinical Development.
• Contribute to global regulatory development plans and participate in CMC strategy discussions at project governance meetings.
• Partner with Process Development, Analytical Development, Quality, and Manufacturing teams to align regulatory strategies with technical and operational objectives in compliance with all applicable regulations and guidance.
• Anticipate and proactively identify regulatory risks, supporting mitigation strategies and recommendations.
• Support cross-functional problem-solving and contribute to decision-making on complex regulatory and CMC development challenges.
• Ensure compliance with applicable laws, regulations, and guidelines by monitoring and interpreting the regulatory landscape, evolving guidance, and external trends relevant to gene therapy.
• Lead preparation, review, and submission of CMC components of INDs, CTAs, BLAs, MAAs, and related amendments/supplements for gene therapy products in accordance with global regulatory requirements.
• Support responses to health authority questions, preparation of briefing packages, and interactions with regulators on CMC matters, including preparation of internal teams for these engagements.
• Collaborate with clinical regulatory colleagues to ensure cohesive and compliant submissions across all modules.
• Support the development and maintenance of Regulatory Affairs programs, policies, and procedures.

Qualifications

• Required: Bachelor’s degree in life sciences or a related field; 10+ years of experience in Regulatory Affairs CMC with at least 5 years focused on gene therapy, viral vectors, or biologics.
• Preferred: Advanced degree (Ph.D., M.S., or equivalent) in Molecular Biology, Biochemistry, Pharmaceutical Sciences, or related discipline.
• Required: Proven success in developing and executing global regulatory CMC strategies for ATMPs or biologics; strong track record of leading CMC submissions (IND/CTA through BLA/MAA) for gene therapy or biologics.
• Required: In-depth understanding of biologics manufacturing, characterization, control strategies, and analytical development; experience interacting directly with global health authorities; previous leadership experience managing teams or cross-functional project workstreams.
• Knowledge & Skills: Expert knowledge of global CMC and gene therapy regulations (FDA CBER, EMA ATMP, ICH Q-series); strong understanding of viral vectors and manufacturing technologies; experience with GXPs and interactions with regulatory agencies; excellent communication, project management, and leadership abilities; self-starter with ability to drive pace in a fast-paced environment.

Skills

• Regulatory strategy development for CMC in gene therapy
• Cross-functional collaboration and project leadership
• Interaction with global health authorities (FDA, EMA, etc.)
• Regulatory intelligence and risk assessment
• IND/CTA/BLA/MAA preparation and submissions
• Technical understanding of viral vectors, manufacturing, and analytical development

Education

• Bachelor’s degree in life sciences or related field required
• Advanced degree (Ph.D., M.S., or equivalent) preferred

Additional Requirements

• Travel to Houston will be required