VP, Regulatory Affairs Strategy

Education

• S. degree in the life sciences or a related discipline required
• Advanced degree (Ph.D., J.D., PharmD, MBA, and/or M.S.) in the life sciences preferred

• Develops and leads integrated global regulatory strategies (US, EU, UK, Japan, and other key markets) for 4DMT’s AAV gene therapy programs from IND through BLA/MAA and approval, aligned with corporate objectives and supported by risk assessments, probability-of-success analyses, and contingency plans.
• Designs global development and submission sequencing, including CTA timing, BLA and MAA filing strategy, and use of FDA–EMA parallel scientific advice and other collaborative review mechanisms.
• Builds regulatory evidence strategies for novel endpoints and trial designs, including surrogate or intermediate endpoints, external controls, and real-world evidence where appropriate, consistent with FDA and EMA expectations for gene therapy.
• Serves as the regulatory lead on program and governance teams, translating regulatory requirements and precedent into development plans, target product profiles, and evidence-generation strategies.
• Identifies and pursues expedited and special regulatory pathways in each region, including Fast Track, RMAT, Breakthrough Therapy, Priority Review, Accelerated Approval, the Commissioner’s National Priority Voucher program, PRIME, ILAP, SAKIGAKE, and orphan designations.
• Plans and leads health authority interactions, including pre-IND, INTERACT, Type A/B/C, End-of-Phase 2, and pre-BLA meetings, EMA scientific advice, and PMDA consultations; directs briefing document strategy and preparation, prepares project teams, and serves as a primary company contact with FDA (CBER/OTP), EMA, and other agencies.
• Leads regulatory strategy for, and oversees preparation of, major submissions, including INDs/CTAs and amendments, annual reports, DSURs, orphan and expedited program designation requests, pediatric plans (iPSP/PIP), and BLA/MAA, ensuring filings are accurate, high quality, and submitted on time.
• Partners with clinical, nonclinical, CMC, biostatistics, safety/pharmacovigilance, and medical affairs to define submission content and to ensure development plans are acceptable to regulators.
• In partnership with Regulatory CMC and Technical Operations, ensures regulatory strategy accounts for AAV-specific CMC topics, including potency assays, comparability, and manufacturing process changes.
• Shapes target product profiles and target labeling strategy across regions in partnership with Medical Affairs and Commercial.
• Provides regulatory strategy input to life cycle plans, including indication expansion, new populations, and post-approval commitments, in partnership with the Life Cycle Management team.
• Partners with Regulatory Operations on submission planning and timelines for global filings.
• Leads ex-US regulatory strategy and execution, adapting global plans to regional requirements (EMA/CAT, MHRA, PMDA, Health Canada, and others) and directing regional partners, CROs, and consultants.
• Partners with Quality to support Pre-Approval Inspection and BIMO readiness, ensuring submitted content is consistent with actual processes and data.
• Builds, leads, and develops the Regulatory Strategy team, including global regulatory leads, with responsibility for goal setting, budget, resourcing, and talent development.
• Educates and trains company employees on regulatory requirements, processes, and health authority expectations.
• Communicates regulatory strategies, risks, and probability of success to executive leadership, the Board as needed, cross-functional teams, and partners/collaborators; supports business development due diligence.
• Maintains current knowledge of the global regulatory environment for gene therapy (including FDA CBER/OTP and EMA CAT/ATMP frameworks), regulatory precedent, and the competitive landscape, and communicates implications to program teams and senior management.
• Shapes the external regulatory environment through engagement with industry groups, health authority workshops, and comments on draft guidance relevant to gene therapy.
• Proactively identifies regulatory risks and proposes solutions that keep development plans on time while maintaining the highest standards of quality and compliance.