Associate Director / Director, Regulatory Affairs
New
Based in the United StatesFull-TimeDirector
Salary$225,000 –$275,000
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Job Details
- Experience
- 7+ years of pharmaceutical or biotech industry experience for Associate Director level (including 6+ years in regulatory affairs), or 10+ years for Director level (including 8+ years in regulatory affairs).
Requirements
- Advanced scientific degree (Ph.D., Pharm.D., M.D., or equivalent) preferred.
- 7+ years of pharmaceutical or biotech industry experience for Associate Director level (including 6+ years in regulatory affairs), or 10+ years for Director level (including 8+ years in regulatory affairs).
- Proven experience leading IND-stage programs and supporting advancement through key regulatory milestones.
- Strong knowledge of early clinical development, translational science, and first-in-human safety considerations.
- Demonstrated experience engaging with global regulatory authorities, including meetings, briefing documents, and written responses.
- Familiarity with rare disease development and accelerated or expedited regulatory pathways.
- Strong cross-functional leadership, communication, and influencing skills.
- Ability to operate effectively in fast-paced, ambiguous environments with limited precedent while maintaining regulatory rigor.
- Ability to clearly communicate regulatory risks, trade-offs, and development implications to support decision-making.
Responsibilities
- Serve as global regulatory lead for assigned programs, defining and executing stage-appropriate regulatory strategies and development pathways.
- Lead regulatory strategy for rare disease programs, including orphan drug designations and expedited development pathways.
- Partner with cross-functional teams (Clinical Development, Translational Sciences, Nonclinical, CMC, and CROs) to integrate regulatory requirements into program planning and decision-making.
- Provide strategic input on study design, biomarkers, dose selection, and first-in-human safety considerations.
- Lead interactions with global health authorities, including preparation of briefing packages, meeting strategy, and formal correspondence.
- Oversee and contribute to regulatory submissions, including INDs, CTAs, amendments, annual reports, and other filings.
- Monitor evolving regulatory guidance and industry trends to inform development strategy and ensure compliance across regions.
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