VP, Regulatory Affairs Strategy
4dmoleculartherapeutics
2 days ago
Full-time
On-site
Emeryville, California
$326,000 - $381,000 USD yearly
Operations
Moneyboard classification: Published base at/above threshold
Reported USD annual base: $326,000–$381,000
Original source: Greenhouse
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration and the second indication is diabetic macular edema, which are both in Phase 3 development. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.
We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:
Dare to Cure
Break Boundaries
Beyond Yourself
Prepare & Execute Relentlessly
Join us in creating the future of genetic medicine.
GENERAL SUMMARY
4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a clinical-stage biotechnology company developing targeted genetic medicines using its proprietary AAV vector platform to treat serious unmet medical conditions. The Vice President, Regulatory Affairs Strategy, reporting to the Chief Regulatory and Quality Officer, is the company’s senior global regulatory strategist, accountable for designing and executing integrated US, EU, and international regulatory strategies that take 4DMT’s programs from IND through BLA/MAA and approval in major markets. The role sets regulatory direction on program and executive teams, leads the company’s most consequential interactions with FDA, EMA, and other health authorities, and leads the Regulatory Strategy team.
MAJOR DUTIES & RESPONSIBILITIES:
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 set
Reported USD annual base: $326,000–$381,000
Original source: Greenhouse
Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.
4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF biologics (aflibercept and anti-VEGF-C) with a single intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration and the second indication is diabetic macular edema, which are both in Phase 3 development. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery.
We are taking genetic medicine to new heights and into new disease areas to overcome challenges not addressed by existing medicines. This incredible challenge drives our relentless and talented team. Our people are the essence of our inspiring, innovative and collaborative environment that encourages individual contributions and provides opportunities for career development. We seek the best in the industry who identify with our mission and our bold and innovative results-driven approach. Our Core Values drive the way we work together:
Dare to Cure
Break Boundaries
Beyond Yourself
Prepare & Execute Relentlessly
Join us in creating the future of genetic medicine.
GENERAL SUMMARY
4D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a clinical-stage biotechnology company developing targeted genetic medicines using its proprietary AAV vector platform to treat serious unmet medical conditions. The Vice President, Regulatory Affairs Strategy, reporting to the Chief Regulatory and Quality Officer, is the company’s senior global regulatory strategist, accountable for designing and executing integrated US, EU, and international regulatory strategies that take 4DMT’s programs from IND through BLA/MAA and approval in major markets. The role sets regulatory direction on program and executive teams, leads the company’s most consequential interactions with FDA, EMA, and other health authorities, and leads the Regulatory Strategy team.
MAJOR DUTIES & RESPONSIBILITIES:
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 set