GondolaBio · 1 week ago
Vice President, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
$288K/yr - $365K/yr
15+ years expGondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. They are seeking a Vice President of Regulatory Affairs to lead and define global regulatory strategies for their pipeline, ensuring successful regulatory interactions and submissions.
BiotechnologyManufacturingPharmaceutical
Responsibilities
Serve as a regulatory leader for GondolaBio’s pipeline, defining stage-appropriate global regulatory strategies, development paths, and decision gates from pre-IND through early proof of concept, with a focus on enabling rapid, high-quality decisions
Develop and execute fit-for-purpose regulatory strategies to support first-in-human and early Phase 1/2 development across multiple modalities, balancing speed, rigor, and long-term optionality, particularly in rare genetic diseases
Lead preparation for and conduct of regulatory interactions with FDA and international health authorities (e.g., EMA and other ex-U.S. agencies), including briefing documents, meeting strategy, scientific advice, and written correspondence
Oversee and contribute directly to the planning, preparation, and submission of high-quality INDs and amendments, ensuring strong integration across nonclinical, clinical, CMC, safety, and translational components, and a track record of successful outcomes
Guide regulatory strategy for rare disease and accelerated development programs, including orphan designation, expedited pathways, and alignment on evidentiary standards appropriate for early proof of concept and downstream development
Shape U.S. and ex-U.S. regulatory strategies for early development, including CTA strategy, country sequencing, and alignment with international clinical and operational plans
Manage external regulatory consultants and vendors as needed, and support regulatory diligence and partnering activities
Qualification
Required
Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent)
15+ years of regulatory affairs experience in pharmaceutical or biotechnology settings, including leadership of regulatory strategy at the program or portfolio level
Demonstrated record of delivering regulatory success, including leading IND-stage programs through key regulatory milestones and early clinical proof of concept
Experience with rare diseases and familiarity with accelerated or expedited regulatory pathways
Proven track record leading interactions with FDA and international health authorities, including briefing documents, meetings, and written responses
Strong understanding of early clinical development, translational biomarkers, and first-in-human safety considerations
Experience operating in small or mid-sized biotech environments where leaders are both strategic and hands-on
Preferred
Familiarity with multiple therapeutic modalities, including oligonucleotides and small molecules
Prior experience serving as the primary regulatory voice with executive leadership, boards, or investment committees
Comfort advising on regulatory risk in the context of business decisions, including asset prioritization, timelines, and capital allocation
Willingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility
Benefits
Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
Flexible PTO
Rapid career advancement for strong performers
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion
Company
GondolaBio
GondolaBio researches, develops and manufactures pharmaceutical products. It is a sub-organization of BridgeBio.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$300M2024-08-16Series Unknown· $300M
Leadership Team
J
James Li
President
Recent News
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