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VP, Regulatory Affairs Strategy at 4D Molecular Therapeutics - ApplyBlast

VP, Regulatory Affairs Strategy

4D Molecular Therapeutics

13 hours ago

3.8 on Glassdoor

Emeryville, California, United States

Hybrid

Full Time

Executive

1 applicant

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About this role

The Vice President, Regulatory Affairs Strategy serves as the senior global regulatory strategist for 4DMT, designing and executing integrated US, EU, and international regulatory strategies for gene therapy programs from IND through approval. This role leads the company's most consequential interactions with health authorities like the FDA and EMA, while overseeing the Regulatory Strategy team and shaping development plans for key product candidates. The position requires extensive experience in viral vector gene therapy and a proven track record of securing regulatory approvals in major markets.

Responsibilities

Develop and lead integrated global regulatory strategies for gene therapy programs
Lead health authority interactions and major regulatory submissions including BLA/MAA
Build and lead the Regulatory Strategy team while ensuring compliance and quality

Skills

Qualifications

Ph.D.J.D.PharmDMBAM.S.

About 4D Molecular Therapeutics

4dmoleculartherapeutics.com

Headquarters

Emeryville, California, United States

Company Size

51-200 employees

Founded

2013

View Profile

4D Molecular Therapeutics (4DMT) is a clinical-stage biotechnology company that designs, develops, and commercializes gene therapies for serious, unmet medical conditions. Using a proprietary AAV capsid engineering and targeted delivery platform, 4DMT creates vectors optimized for tissue specificity, potency, and manufacturability to improve safety and therapeutic benefit. The company focuses on translational programs across ocular, neuromuscular, central nervous system, and cardiopulmonary indications and partners to advance candidates toward clinical and commercial development.