Head of Regulatory Affairs

About Us

ARTBIO is re-defining cancer care by developing a new class of radioligand therapies (RLT) which harness the power of 212Pb and deliver it directly to the tumour. Targeted RLT is one of the fastest growing areas of oncology research and investment. The foundational technology, termed AlphaDirect, was born out of elegant research by our scientific founders, Roy Larsen and Øyvind Bruland, inventors of XofigoTM. ARTBIO is leveraging this groundbreaking science and expediting novel Drug Discovery targets which broadly exploit the unmet medical need and opportunity in revolutionising cancer care. Supported by a committed investment board including Omega Funds, F-Prime Capital, Radforsk and Third Rock Ventures, ARTBIO has built a highly experienced, multi-disciplinary team of drug-hunters and developers. For more information on our strategy and emerging pipeline, please visit www.artbio.com and follow-us on LinkedIn.

As an emerging, global biotech with locations in Boston, Massachusetts, Basel, Switzerland, London, England and Oslo, Norway, we take advantage of diverse scientific depth and insights which makes ARTBIO a unique place to work. We are driven by a desire to do better for cancer patients, lowering the burden of toleration and safety while at the same time raising the bar on clinical efficacy and duration.

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 processeswithin clinical manufacturing, quality assurance and investigational drug release and a proven track record of successfully navigating regulatory landscapes in the biotech or pharmaceutical industry

Key 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 investigational drug development and manufacturing.

· 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 in the oncology therapeutic area.

· 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.

EEO Statement: ARTBIO is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. If you have a disability or special need that requires accommodation, please let us know.