VP, Regulatory Affairs Strategy

4D Molecular Therapeutics•Emeryville, CA

2d•$326,000 - $381,000•Hybrid

About The Position

4D Molecular Therapeutics (4DMT), located in Emeryville, California, is a clinical-stage biotechnology company developing targeted genetic medicines using a proprietary AAV vector platform. The Vice President, Regulatory Affairs Strategy reports to the Chief Regulatory and Quality Officer and serves as the company’s senior global regulatory strategist. The role designs and executes integrated US, EU, and international regulatory strategies to advance programs from IND through BLA/MAA and approval in major markets, sets regulatory direction on program and executive teams, leads key health authority interactions, and leads the Regulatory Strategy team. The position develops regulatory approaches for 4DMT’s AAV gene therapy programs, including global development and filing sequences, evidence-generation strategies, submission plans, expedited pathways, target product profiles, labeling, and lifecycle plans. It leads major interactions with FDA, EMA, and other health authorities, and oversees regulatory strategy and preparation for major submissions. The role works closely with clinical, nonclinical, CMC, biostatistics, safety/pharmacovigilance, medical affairs, regulatory operations, quality, technical operations, and lifecycle management colleagues, as well as regional partners and external consultants. The VP builds and develops the Regulatory Strategy team, communicates regulatory risks and probability of success to senior leaders and other stakeholders, supports business-development diligence, and keeps the company informed about the global gene therapy regulatory environment. The position is hybrid or onsite, with an expectation to work onsite in Emeryville at least three times per month, and requires 15–25% travel, including international travel.

Requirements

Bachelor’s degree in life sciences or a related discipline required.
18+ years of biopharmaceutical or biotechnology industry experience, or 14+ years with an M.S. degree, or 10+ years with a Ph.D. or PharmD; the majority of experience must be in Regulatory Affairs.
8+ years of people-management experience leading regulatory strategy teams; equivalent combinations of education and experience will be considered.
Experience in the viral vector gene therapy field required; direct experience with FDA CBER/OTP required.
Senior responsibility for at least one successful BLA or MAA, preferably for gene therapy, cell therapy, or a biologic, including direct ownership of global US and EU regulatory strategy through approval.
Demonstrated success negotiating novel development plans, endpoints, or expedited pathways with FDA CBER/OTP and EMA.
Track record leading EU regulatory strategy, including EMA scientific advice, PRIME or CAT interactions, and centralized MAA procedures.
Experience obtaining expedited program designations such as RMAT, Breakthrough Therapy, Fast Track, PRIME, or orphan designation.
Expert knowledge of global regulations and guidance, including FDA, EMA, ICH, MHRA, and PMDA, and how they inform integrated global regulatory strategy.
Proven ability to develop and execute global regulatory strategies that deliver approvals.
Strong collaborative working relationships with FDA, EMA, and other health authorities that have led to successful business outcomes.
Ability to work in a team environment, report on projects, and drive them to conclusions.
Self-starter with a sense of urgency and the ability to collaborate with other disciplines.
Adaptability, flexibility, independence, and resourcefulness to work hands-on and multitask in a small-company environment.
Ability to identify challenges proactively, exercise strategic foresight, and implement appropriate courses of action.
Thorough knowledge of drug development and regulatory submission processes.
Excellent scientific and regulatory writing skills, including briefing documents and responses to health authority questions.
Demonstrated experience preparing and filing FDA and EMA submissions, including a BLA or MAA.
Excellent organizational, communication, and time-management skills.
Ability to innovate, analyze, and solve problems with minimal supervision and strong attention to detail.
Ability to travel 15–25%, including internationally.
Expected to work onsite in Emeryville, California, at least three times per month.

Nice To Haves

Advanced degree in life sciences, such as a Ph.D., J.D., PharmD, MBA, and/or M.S.
AAV experience is highly desirable.
Japan or other international regulatory experience.
Ophthalmology or pulmonology experience.

Responsibilities

Develop and lead integrated global regulatory strategies for AAV gene therapy programs across the US, EU, UK, Japan, and other key markets, from IND through BLA/MAA and approval.
Design global development and submission sequencing, including CTA timing, BLA/MAA filing strategy, and collaborative review mechanisms such as FDA–EMA parallel scientific advice.
Develop regulatory evidence strategies for novel endpoints and trial designs, including surrogate or intermediate endpoints, external controls, and real-world evidence where appropriate.
Serve as regulatory lead on program and governance teams, translating regulatory requirements and precedent into development plans, target product profiles, and evidence-generation strategies.
Identify and pursue expedited and special regulatory pathways and designations in relevant regions.
Plan and lead health authority interactions, including FDA meetings, EMA scientific advice, and PMDA consultations; direct briefing-document strategy and preparation, prepare project teams, and serve as a primary company contact with agencies.
Lead regulatory strategy for and oversee preparation of major submissions, including INDs/CTAs and amendments, annual reports, DSURs, designation requests, pediatric plans, and BLA/MAA filings; ensure filings are accurate, high quality, and timely.
Partner with clinical, nonclinical, CMC, biostatistics, safety/pharmacovigilance, and medical affairs teams to define submission content and ensure development plans are acceptable to regulators.
Partner with Regulatory CMC and Technical Operations to address AAV-specific CMC topics, including potency assays, comparability, and manufacturing process changes.
Shape target product profiles and target labeling strategy across regions with Medical Affairs and Commercial.
Provide regulatory strategy input to lifecycle plans, including indication expansion, new populations, and post-approval commitments.
Partner with Regulatory Operations on global submission planning and timelines.
Lead ex-US regulatory strategy and execution, adapting global plans to regional requirements and directing regional partners, CROs, and consultants.
Partner with Quality to support Pre-Approval Inspection and BIMO readiness and ensure submitted content is consistent with actual processes and data.
Build, lead, and develop the Regulatory Strategy team, including global regulatory leads; set goals and oversee budget, resourcing, and talent development.
Educate and train employees on regulatory requirements, processes, and health authority expectations.
Communicate regulatory strategies, risks, and probability of success to executive leadership, the Board as needed, cross-functional teams, and partners or collaborators; support business-development due diligence.
Maintain knowledge of the global gene therapy regulatory environment, regulatory precedent, and the competitive landscape, and communicate implications to program teams and senior management.
Engage with industry groups and health authority workshops and comment on draft guidance to help shape the external regulatory environment.
Proactively identify regulatory risks and propose solutions that keep development plans on time while maintaining high standards of quality and compliance.