Head of Regulatory Affairs

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

Requirements

15+ years of regulatory affairs experience in the biotech or pharmaceutical industries, with emphasis on drug development; 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; Demonstrated ability to navigate complex regulatory landscapes and anticipate and mitigate potential regulatory risks

Nice to have

Advanced degree (JD, PhD, PharmD, MD or equivalent) in a scientific discipline; Familiarity with radiopharmaceuticals; Comfortable working in a fast-paced biotech environment; Commitment to safety and continuous improvement

Benefits

A unique chance to contribute to first-in-class cancer therapies; Exposure to both radiochemistry and CMC development in a dynamic biotech setting; Hands-on training and professional development opportunities; An international, collaborative, and supportive work culture; Competitive compensation and benefits