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 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.

- Familiarity with radiopharmaceuticals is a plus.

Personal Attributes

- Foster a culture of excellence, collaboration, and continuous learning.

- Proactive, detail-oriented, and eager to learn.

- Comfortable working in a fast-paced biotech environment.

- Team player who thrives on collaboration and cross-functional flexibility.

- Commitment to safety and continuous improvement.

What We Offer

- 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.

About Us

Channeling Energy. Changing Lives. ARTBIO redefines cancer care by discovering and developing a new class of Alpha Radioligand Therapies (ARTs), powered by unique Pb-212 isotope technology and seamless supply. Our team works tirelessly to bring therapies that matter to patients who need them.

The unique ARTBIO approach selects the optimal alpha-precursor isotope (212Pb) and tumor-specific targets to create therapeutics with the potential for the highest efficacy and safety. The company's AlphaDirect™ technology, a first-of-its-kind 212Pb isolation method, enables a distributed manufacturing approach for the reliable production and delivery of ARTs. ARTBIO is advancing multiple pipeline programs, with lead program AB001 currently in first-in-human trials. The