Associate Director/Director, Regulatory Affairs

Description

About GondolaBio

GondolaBio is a clinical-stage biopharmaceutical company focused on developing breakthrough therapeutics for genetic diseases. GondolaBio is an independent sister company to BridgeBio, originally carved out in 2024 after securing $300M in private financing from external investors. GondolaBio aims to leverage cutting-edge biological research to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases.

Who You Are

You are an experienced regulatory affairs professional with expertise in early clinical development and a strong track record of advancing innovative therapies through key regulatory milestones. You are comfortable leading regulatory strategy for one or more development programs while partnering closely with cross-functional teams in a small, fast-moving biotech environment.

You thrive at the intersection of science, clinical development, and regulatory execution, bringing a pragmatic, solutions-oriented mindset to navigating complex regulatory pathways, including those relevant to rare diseases and accelerated development. You are equally comfortable developing strategy and driving execution, ensuring that regulatory plans are aligned with program objectives and business priorities.

Key Responsibilities

• •Serve as the global regulatory lead for assigned development programs, defining stage-appropriate regulatory strategies and development pathways.
• •Develop regulatory strategy for rare disease and accelerated development programs, including orphan designation applications and expedited development pathways.
• •Partner closely with Clinical Development, Translational Sciences, Nonclinical, CMC, and other functional teams, including working with CROs as needed, to integrate regulatory considerations into development planning and key program decisions.
• •Provide strategic regulatory input on study design, translational biomarkers, dose selection, and first-in-human safety considerations.
• •Provide regulatory guidance to support efficient and informed decision-making while balancing development speed, scientific rigor, and long-term program optionality.
• •Lead preparation for and interactions with global health authorities, including briefing documents, meeting strategy, and written correspondence.
• •Lead and contribute directly to the planning, preparation, and submission of high-quality regulatory submissions (e.g., IND, CTA), amendments, annual reports, and other regulatory filings.
• •Maintain awareness of evolving regulatory guidance and industry trends that may impact development strategies.
• •Support global development efforts by evaluating regional regulatory requirements and opportunities.

Requirements

Preferred Education & Experience

• •Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred.
• •For Associate Director, we expect 7+ years of pharmaceutical/biotechnology industry experience, at least 6 of which should be regulatory experience; for Director, we expect 10+ years of pharmaceutical/biotechnology industry experience, at least 8 of which should be regulatory experience.
• •Demonstrated record of regulatory success, including leading and supporting IND-stage programs through key regulatory milestones and supporting advancement through development.
• •Experience with rare diseases and familiarity with accelerated or expedited regulatory pathways.
• •Proven track record leading and supporting interactions with regulatory authorities, including briefing documents, meetings, and written responses.
• •Strong understanding of early clinical development, translational biomarkers, and first-in-human safety considerations.
• •Strong cross-functional leadership and communication (written and verbal) skills.

Nice-to-Haves

• •Familiarity with multiple therapeutic modalities, including oligonucleotides and small molecules.
• •Ability to communicate regulatory risks, opportunities, and development tradeoffs in support of program decision-making.
• •Willingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility.

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

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
• •A decentralized 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 (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
• •Commitment to Diversity, Equity & Inclusion

The base pay range for this position is $200,000 -$240,000 per year. The actual compensation offered will be determined based on a number of job-related factors, including experience, skills, qualifications, and location.

GondolaBio ServiceCo is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Employees of GondolaBio and all affiliated companies should work through their managers to inquire about and learn more about this role.

Fraud Alert: We are aware of employment scams where individuals pose as representatives of GondolaBio and make false use of our company name to defraud job seekers. To protect yourself, please note that our official corporate website is https://gondolabio.com/ ; our careers page is https://gondolabio.com/#careers ; our LinkedIn page is https://www.linkedin.com/company/gondolabio/ . Please visit these links for official information from GondolaBio. Communication from any other variant is fraudulent. GondolaBio does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without interviews.