Learn about how ARTBIO is redefining cancer care through a new class of alpha radioligand therapies and building an ecosystem to maximize their potential. Backed by Third Rock Ventures.
About the role
The Head of Regulatory Affairs leads ARTBIO’s regulatory function for clinical-stage radiopharmaceutical programs, ensuring clear strategy, compliant execution, and effective engagement with health authorities. This is a key leadership position that requires a deep understanding of regulatory processes and a proven track record of successfully navigating regulatory landscapes in the biotech or pharmaceutical industry.
What they're looking for
- Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline is preferred
- 15+ years of regulatory affairs experience in the biotech or pharmaceutical industries, with emphasis on drug development
- Possess in-depth knowledge of global regulatory requirements and guidelines, including FDA, and EMA regulations and international regulatory frameworks
- Proven track record of successful regulatory submissions, including INDs, NDAs, BLAs and MAAs
- Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas
- Strong understanding of drug development processes, CMC, quality, and clinical trial regulations
More about this role
Summary
The Head of Regulatory Affairs leads ARTBIO’s regulatory function for clinical-stage radiopharmaceutical programs, ensuring clear strategy, compliant execution, and effective engagement with health authorities. This is a key leadership position that requires a deep understanding of regulatory processes and a proven track record of successfully navigating regulatory landscapes in the biotech or pharmaceutical industry.
- Define and lead global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical programs.
- Lead key regulatory submissions, including INDs, CTAs, and DMFs.
- Lead FDA and global health authority interactions, including meeting preparation, briefing packages, responses, and follow-up actions.
- Ensure compliance with regulatory requirements throughout the drug development lifecycle, including clinical trials and manufacturing.
- Proactively identify potential regulatory risks and develop mitigation strategies.
- Identify regulatory risks, advise executive leadership on timelines and decision points.
- Partner with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to...
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