Senior Executive Director Regulatory Affairs - Advanced Genetic Medicine
About The Position
The Senior Executive Director of Regulatory Affairs for Advanced Genetic Medicines provides strategic leadership for regulatory affairs across a diverse development portfolio, enabling the efficient advancement of innovative medicines while ensuring compliance with worldwide regulatory standards. This key R&D leader shapes portfolio strategy, regulatory policy, and organizational capabilities, and oversees the institution's regulatory activities related to gene editing and other advanced genetic therapies. The role also supports clinical research and product development and provides regulatory advice and strategy for investigational products and assets. The position provides regulatory strategy and operational leadership for investigational therapies, including INDs, BLAs, and associated interactions, and ensures compliance with FDA regulations and institutional policies. It partners with investigators, sponsors, and cross-functional teams to facilitate efficient development and conduct of clinical trials. The role requires extensive regulatory affairs and FDA-interaction experience, project management expertise, advanced knowledge of FDA regulations and ICH/GCP guidelines, and leadership and communication skills in complex research environments.
Requirements
- Bachelor's degree.
- At least 12 years of gene therapy clinical research experience.
- At least 12 years of related regulatory experience, including gene therapy INDs, BLA preparation, and collaboration with the FDA, IRBs, and other regulatory authorities.
- At least 12 years of gene therapy grant-writing experience.
- At least 12 years of intellectual property development experience.
- Advanced proficiency in establishing and implementing novel U.S. and E.U. treatment regulatory and clinical strategies, from preclinical through registration phases and across multiple therapeutic areas.
- Advanced proficiency in clinical research management, trial conduct, and clinical-trial oversight.
- Advanced knowledge of FDA and other regulatory agency gene therapy guidelines, including IND/IDE requirements and DSMP and DSMB charter development.
- Advanced knowledge of federal, state, and local regulations for human research subject protections, including ICH/GLP/GCP/GMP guidelines.
- Advanced knowledge of gene therapy regulatory pathways, designations, and pharmaceuticals, including FDA Orphan Designation, breakthrough therapy, and potential novel regulatory pathways.
- Advanced knowledge of product manufacturing, including related quality assurance and quality control systems.
- Ability to effectively manage competing priorities.
Nice To Haves
- Master's degree.
Responsibilities
- Lead regulatory planning from preclinical development through marketing authorization and lifecycle management for advanced genetic therapies, including gene-editing products.
- Provide strategic guidance for INDs, CTAs, BLAs, MAAs, and post-approval activities.
- Contribute to executive decision-making regarding development strategy and regulatory risk.
- Serve as the primary regulatory liaison with the FDA and other regulatory agencies for submissions, communications, and inquiries.
- Assist research teams with the pre-IND and IND filing process for Phase I/II human trials and beyond.
- Provide investigators and study teams with regulatory guidance on requirements, timelines, and compliance.
- Lead regulatory document management to ensure accuracy, completeness, and audit readiness.
- Coordinate responses to FDA information requests and regulatory submissions.
- Participate in FDA meetings, including pre-IND and Type B/C meetings.
- Collaborate with faculty, the Clinical In Vivo Gene Therapy group, and the Orphan Disease Center as a resource for developing IND/IDE studies, making substantial amendments to ongoing IND/IDE studies, and developing or revising industry-sponsored protocols.
- Ensure timely development and submission of regulatory documents, including briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, and IND safety reports.
- Lead cross-functional teams in preparing for regulatory agency meetings.
- Ensure compliance with FDA regulations; establish quality policies, practices, procedures, and standards; develop and maintain a quality management system for GxP activities; and implement process improvements.
- Interact with relevant academic and industry collaborators in collaboration with faculty and Clinical In Vivo Gene Therapy group members, serving as a key point of contact on behalf of CHOP.
- Recruit and mentor regulatory and research team members.
- Anticipate changes in regulatory policy and incorporate evolving requirements into development strategies.
- Align regulatory activities with clinical, scientific, manufacturing, and quality stakeholders.
- Assist genome-editing staff in developing and implementing investigator and coordinator education and training to improve clinical-trial research quality at CHOP.
- Advise investigators on developing Data Safety Monitoring Plans and ensure proposed CHOP studies comply with applicable federal, state, and international clinical-trial research requirements.
- Work with academic and/or industry manufacturing colleagues on CMC regulatory package strategy and preparation.
Benefits
- The job is eligible for an incentive program.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
