Associate Director – Regulatory Affairs

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $200k - $240k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 3%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 45 days.

Apply Now

Find Similar Remote Jobs

GondolaBio

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2024

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 $300M Venture Round - GondolaBio on 2024-08

Healthcare • Consulting • Manufacturing

GondolaBio is a clinical-stage biopharmaceutical company launched in 2024 and affiliated with BridgeBio Pharma, focused on developing breakthrough therapeutics for patients with genetic diseases. The company uses a lean, decentralized approach to accelerate early-stage research and development across multiple modalities (including small molecules and oligonucleotide therapies) and is building a diverse pipeline targeting rare and underserved genetic conditions such as EPP/XLP with its lead program PORT-77. GondolaBio centers patient needs and aims to bring disease-modifying treatments more quickly to populations lacking approved therapies.

📋 Description

• Serve as the global regulatory lead for assigned development programs • Define stage-appropriate regulatory strategies and development pathways • Develop regulatory strategy for rare disease and accelerated development programs • Prepare orphan designation applications and support expedited development pathways • Partner with Clinical Development, Translational Sciences, Nonclinical, CMC, other functional teams, and CROs • Integrate regulatory considerations into development planning and key program decisions • Provide regulatory input on study design, translational biomarkers, dose selection, and first-in-human safety considerations • Provide guidance for efficient decision-making while balancing development speed, scientific rigor, and program optionality • Lead preparation for and interactions with global health authorities • Develop briefing documents, meeting strategies, and written correspondence • Lead and contribute to regulatory submissions, including INDs, CTAs, amendments, annual reports, and other filings • Monitor evolving regulatory guidance and industry trends • Evaluate regional regulatory requirements and opportunities to support global development efforts

🎯 Requirements

• Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred • Associate Director: 7+ years of pharmaceutical/biotechnology industry experience, including at least 6 years of regulatory experience • Director: 10+ years of pharmaceutical/biotechnology industry experience, including at least 8 years of regulatory experience • Demonstrated record of regulatory success, including leading and supporting IND-stage programs through key regulatory milestones • 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 written and verbal communication skills • Familiarity with multiple therapeutic modalities, including oligonucleotides and small molecules • Ability to communicate regulatory risks, opportunities, and development tradeoffs • Willingness and ability to operate with limited precedent and incomplete data while maintaining regulatory credibility

🏖️ Benefits

• Patient Days • Culture inspired by company values • Decentralized operating model with decision-making authority close to the science • Career ownership and development opportunities • Collaborative, fast-paced, data-driven environment • Access to learning and development resources • Robust and market-competitive health, welfare, and retirement programs • Flexible PTO • Rapid career advancement for strong performers • Potential ability to work on multiple GondolaBio programs across multiple therapeutic areas

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume