Head of Regulatory Affairs

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.

### Responsibilities

* 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 support timely, high-quality submissions. * Serve as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authorities. * Monitor regulatory policy changes and provide practical guidance to internal teams on requirements, risks, and opportunities. * Build regulatory capability through team leadership, mentoring, training, and strong cross-functional collaboration. ### Qualifications & Education

• 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 guideline