VP, Regulatory Affairs Strategy

The role

The Vice President, Regulatory Affairs Strategy designs and executes integrated global regulatory strategies from IND through BLA/MAA and approval. This person leads the Regulatory Strategy team and manages consequential interactions with health authorities like the FDA and EMA.

What you will do

• Develops and leads integrated global regulatory strategies for AAV gene therapy programs
• Designs global development and submission sequencing
• Builds regulatory evidence strategies for novel endpoints and trial designs
• Serves as the regulatory lead on program and governance teams
• Identifies and pursues expedited and special regulatory pathways
• Plans and leads health authority interactions
• Leads regulatory strategy for and oversees preparation of major submissions
• Partners with clinical, nonclinical, CMC, biostatistics, safety, and medical affairs
• Leads ex-US regulatory strategy and execution
• Builds, leads, and develops the Regulatory Strategy team

Required qualifications

• BS degree in the life sciences or a related discipline
• 18+ years of experience in biopharmaceutical or biotechnology industries, or 14+ years with an M.S. degree, or 10+ years with a PhD or PharmD, with the majority in Regulatory Affairs
• 8+ years of people management experience leading regulatory strategy teams
• Experience within the viral vector gene therapy field
• Direct experience with FDA CBER/OTP
• Senior responsibility for at least one successful BLA or MAA
• Demonstrated success negotiating novel development plans, endpoints, or expedited pathways with FDA CBER/OTP and EMA
• Demonstrated experience preparing and filing FDA and EMA submissions, including a BLA or MAA
• Expert knowledge of global regulations and guidance (FDA, EMA, ICH, MHRA, PMDA)
• Excellent scientific and regulatory writing skills
• Excellent organizational, communication and time management skills

Nice to have

• Advanced degree (Ph.D., J.D., PharmD, MBA, and/or M.S.) in the life sciences
• AAV experience
• Gene therapy, cell therapy, or biologic experience for BLA or MAA
• Japan or other international experience
• Ophthalmology or pulmonology experience

Before you apply

• No unsolicited resumes from agencies will be accepted

About the company

4D Molecular Therapeutics (4DMT) is a clinical-stage biotechnology company developing targeted genetic medicines using its proprietary AAV vector platform to treat serious unmet medical conditions.