Vice President, Regulatory Affairs
Full-timeSeniorRegulatory AffairsAutoimmune DiseasesCell TherapyPhD
Market Rate — Natural Sciences Managers
25th
$120K
Median
$158K
75th
$205K
BLS 2024 data (national)
Description
The Vice President of Regulatory Affairs is responsible for driving success and will lead the global regulatory strategy and execution for an advanced cell therapy product development program. This role includes ensuring compliance with all applicable regulations, guiding interactions with health authorities (FDA, EMA, and other global agencies), and driving successful regulatory submissions and approvals. Responsibilities include developing and implementing global regulatory strategies, overseeing content preparation and submissions, building relationships with regulatory agencies, and leading a high-performing team.
Requirements
Advanced degree in life sciences, pharmacy, or related field (PhD, PharmD, or equivalent preferred). 15+ years of regulatory affairs experience in biopharmaceuticals from pre-clinical to commercialization, with at least 8 years in leadership roles. Experience in cell and gene therapy field is preferred. Proven track record of successful IND and BLA submissions (prior BLA experience required). Deep knowledge of FDA CBER regulations, EMA ATMP guidelines, GxPs, and global regulatory frameworks. Strong leadership, strategic thinking, and negotiation skills. Excellent communication and stakeholder management abilities. Strong team orientation and passion for continuous self-development.
Cabaletta Bio
BIOTECHNOLOGY
Chimeric Auto Antibody Receptors
LocationPHILADELPHIA, PA
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