Associate/ Director, Regulatory Affairs

GondolaBio Service Co•Palo Alto, CA

About The Position

GondolaBio is seeking a Regulatory Affairs leader to own the global regulatory strategy and execution for Portal's program, driving plans, timelines, and cross-functional coordination for filings. Reporting to the Head of Regulatory Affairs, this role is both strategic and hands-on, involving health authority interactions, project management for major submissions, and serving as the regulatory voice on the program team. Prior ownership of an NDA or BLA is essential. The company is focused on developing next-generation therapeutics for genetic diseases and aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines. Portal Therapeutics is their lead program, developing a therapy for erythropoietic protoporphyria, a severe genetic disease of the blood.

Requirements

Bachelor’s degree in a scientific discipline required
Minimum 5 years of regulatory affairs experience in the biotech or pharmaceutical industry for Associate Director; 8 years for Director
Direct, hands-on experience managing or leading a major marketing application (NDA or BLA)
Demonstrated project management experience — building and driving integrated submission timelines, leading cross-functional teams to deliverables, and managing scope, dependencies, and risk
Experience leading successful FDA interactions, including authoring or owning briefing documents and preparing teams for pre-IND, Type B/C, End-of-Phase 2, and pre-NDA/BLA meetings
Experience with rare or genetic disease programs, including orphan drug designation and expedited development pathways (Fast Track, Breakthrough Therapy, RMAT, accelerated approval, rare pediatric disease priority review vouchers)
Working knowledge of CTD/eCTD structure, ICH guidelines, 21 CFR, and electronic submission publishing processes
Motivated to work in a fast-paced, highly accountable, small company environment
A collegial professional who leads through influence and interpersonal skills, with demonstrated ability to collaborate successfully across functions and with external vendors
Able to proactively identify and solve problems under pressure, and to make pragmatic recommendations where guidance is ambiguous
Capable of prioritizing tasks and delivering on deadlines with high performance standards and attention to detail
Strong written and oral communication skills, including the ability to present regulatory strategy and risk clearly to senior leadership
Solid critical, strategic, and analytical thinking skills

Nice To Haves

Advanced degree (MS, PhD, PharmD, or equivalent) preferred
Experience leading others or leading cross-functional teams
Experience carrying an NDA or BLA from content planning through submission and approval is strongly preferred
Formal project management training or certification (e.g., PMP) a plus
Experience with ex-US health authorities (EMA/MAA, Health Canada, MHRA) a plus but not required
Some travel required

Responsibilities

Drive the global regulatory strategy for the program from clinical development through submission and approval, and translate that strategy into actionable, milestone-driven regulatory plans
Serve as project manager and primary point of accountability for major regulatory submissions — INDs/CTAs and amendments, briefing books, designation requests, annual reports, and NDA/BLA modules — including content plans, timelines, and tracking of cross-functional deliverables
Lead preparation and execution of FDA and other health authority interactions, including briefing documents, question strategy, team rehearsals, and follow-up on commitments
Build and maintain integrated submission timelines; identify critical path risks early and drive mitigation with functional leads and senior management
Author, review, and approve submission documents in partnership with clinical, nonclinical, CMC, biometrics, safety, and medical writing, ensuring accuracy, consistency, and inspection-ready quality
Provide day-to-day regulatory guidance on protocols, informed consent forms, investigator brochures, safety reporting, labeling, and scientific communications
Monitor and interpret the evolving regulatory landscape and precedent in rare and genetic disease; advise leadership on implications and on opportunities such as orphan drug designation, expedited pathways, and accelerated approval
Manage regulatory consultants, publishing vendors, and ex-US partners or agents; oversee scope, budget, and quality of outsourced regulatory work
Maintain regulatory documentation, submission archives, and compliance with applicable regulations and internal SOPs

Benefits

Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
Flexible PTO
Access to learning and development resources
Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
An unyielding commitment to always putting patients first
A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
A place where you own the vision – both for your program and your own career path
A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
Rapid career advancement for strong performers
Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas over time
Partnerships with leading institutions
Commitment to Diversity, Equity & Inclusion