This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director / Director, Regulatory Affairs based in the United States.
This role sits at the core of advancing innovative therapies for genetic diseases, with responsibility for shaping and executing regulatory strategies across early clinical development programs. You will operate in a highly dynamic biotech environment where science, clinical development, and regulatory execution intersect. The position requires a strategic mindset paired with strong hands-on capability to guide programs through complex global regulatory pathways, including rare disease and expedited development frameworks. You will partner closely with cross-functional teams such as Clinical Development, CMC, Translational Sciences, and Nonclinical to ensure regulatory alignment at every stage of development. A key part of the role involves direct engagement with global health authorities and ownership of high-quality regulatory submissions. This is a high-impact opportunity to help bring transformative genetic disease therapies closer to patients while working in a fast-paced, science-driven environment.
Accountabilities:
- 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.
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.
- Nice-to-have: familiarity with multiple therapeutic modalities such as oligonucleotides and small molecules.
- Ability to clearly communicate regulatory risks, trade-offs, and development implications to support decision-making.
Benefits:
- Competitive compensation package including base salary ($225,000–$275,000), performance bonus, and equity.
- Comprehensive health, dental, vision, life, and retirement benefits.
- Flexible PTO and strong emphasis on work-life balance.
- Remote-friendly and flexible work culture within a decentralized operating model.
- Opportunity to contribute to cutting-edge therapies for genetic diseases with high patient impact.
- Strong culture of scientific rigor, transparency, and patient-first values.
- Access to learning, development, and rapid career advancement opportunities.
- Exposure to multiple programs and therapeutic areas within a growing biotech environment.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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