Who You AreA regulatory affairs leader who owns global regulatory strategy and execution for Portal's program and drives the plans, timelines, and cross-functional coordination that turn that strategy into filings. Reporting to the Head of Regulatory Affairs, this role is both strategic and hands-on: you will lead health authority interactions, serve as the project manager for major submissions, and act as the regulatory voice on the program team. Prior ownership of an NDA or BLA is essential.
Requirements
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
No matter your role at GondolaBio, successful team members are:- Patient Champions, who put patients first and uphold strict ethical standards
- Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
- Truth Seekers, who are detailed, rational, and humble problem solvers
- Individuals Who Inspire Excellence in themselves and those around them
- High-quality executors, who execute against goals and milestones with quality, precision, and speed
Education, Experience & Skills Requirements- Bachelor's degree in a scientific discipline required; advanced degree (MS, PhD, PharmD, or equivalent) preferred
- Minimum 5 years of regulatory affairs experience in the biotech or pharmaceutical industry for Associate Director; 8 years for Director, including experience leading others or leading cross-functional teams
- Required: direct, hands-on experience managing or leading a major marketing application (NDA or BLA). Experience carrying an NDA or BLA from content planning through submission and approval is strongly preferred
- Demonstrated project management experience - building and driving integrated submission timelines, leading cross-functional teams to deliverables, and managing scope, dependencies, and risk. Formal project management training or certification (e.g., PMP) a plus
- Track record of 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
- Experience with ex-US health authorities (EMA/MAA, Health Canada, MHRA) a plus but not required
- 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
- Some travel required
What We Offer - 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. Learn more about how we do this here
- 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
- Access to learning and development resources to help you get in the best professional shape of your life
- Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
- Flexible PTO
- 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
The base pay range for this position is $211,000 to $ 250,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered.
