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Associate Director – Regulatory Affairs
GondolaBio. Serve as the global regulatory lead for assigned development programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing regulatory strategies for rare diseases and accelerated development programs, with a strong focus on leading regulatory submissions and interactions with global health authorities. Possesses advanced knowledge of early clinical development, translational biomarkers, and regulatory compliance.
Highest-signal resume keywords
Regulatory Strategy DevelopmentIND Submission ExperienceCross-Functional LeadershipRare Disease ExpertiseRegulatory Authority Interaction
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory SubmissionsINDsCTAsRegulatory MilestonesTranslational BiomarkersFirst-In-Human SafetyAccelerated Development PathwaysOrphan Designation ApplicationsRegulatory Guidance MonitoringPharmaceutical Industry Experience
Soft Skills
Written CommunicationVerbal CommunicationDecision-MakingLeadershipCollaboration
Certifications & Qualifications
Ph.D.Pharm.D.M.D.
Industry Keywords
PharmaceuticalBiotechnologyRegulatory AffairsClinical DevelopmentOligonucleotidesSmall MoleculesGlobal Health AuthoritiesRegulatory RisksDevelopment TradeoffsCROs
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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