Director, Regulatory Affairs CMC

Position Overview

We are seeking a Director, Regulatory Affairs CMC to join the Regulatory Affairs CMC team to support a novel rare disease CNS pipeline. The individual will provide CMC regulatory input to cross-functional teams, contribute to global regulatory development plans, and partner with Process Development, Analytical Development, Quality, and Manufacturing teams to align regulatory strategies with technical and operational objectives.

Requirements

• Accountability and 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.

Minimum Requirements

• Education
• Bachelor’s degree in life sciences or a related field required
• Advanced degree (Ph.D., M.S., or equivalent) in Molecular Biology, Biochemistry, Pharmaceutical Sciences, or a related discipline preferred

• Experience
• 10+ years of experience in Regulatory Affairs CMC
• 5 years focused on gene therapy, viral vectors, or biologics
• BLA experience required

• Proven success in developing and executing global regulatory CMC strategies for advanced therapy medicinal products (ATMPs) or biologics
• Strong track record of leading CMC submissions (IND/CTA through BLA/MAA) for gene therapy or biologics
• In-depth understanding of biologics manufacturing, characterization, control strategies, and analytical development

• Experience interacting directly with global health authorities
• Prior leadership experience managing teams or cross-functional project workstreams

• Knowledge and Skills
• Expert knowledge of global CMC and gene therapy-specific regulations and guidance (FDA CBER, EMA ATMP, ICH Q-series)
• Strong scientific understanding of viral vectors (AAV, lentivirus, etc.), manufacturing technologies, and quality control principles
• Extensive experience with applicable regulatory requirements, including GXPs, and previous interactions with FDA, EMA, and other regulatory agencies

• Exceptional interpersonal and communication skills, with the ability to interact effectively with senior leaders, cross-functional teams, and colleagues at all levels while exercising sound regulatory judgment in complex situations
• Strong project management, organizational, and leadership abilities, with the capacity to prioritize and drive initiatives efficiently in a fast-paced environment
• Excellent written and verbal communication skills
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance and results
• Ability to track and measure performance against defined metrics
• Self-starter with high degree of energy, independence, initiative, and self-motivation, as illustrated by the ability to instill a sense of pace and urgency into the team
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families

Travel

• Travel to Houston will be required