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 programsLead key regulatory submissions, including INDs, CTAs, and DMFsLead FDA and global health authority interactions, including meeting preparation, briefing packages, responses, and follow-up actionsEnsure compliance with regulatory requirements throughout the drug development lifecycle, including clinical trials and manufacturingProactively identify potential regulatory risks and develop mitigation strategiesIdentify regulatory risks, advise executive leadership on timelines and decision pointsPartner with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to support timely, high-quality submissionsServe as the primary point of contact for regulatory agencies and build strong relationships with key regulatory authoritiesMonitor regulatory policy changes and provide practical guidance to internal teams on requirements, risks, and opportunitiesBuild 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 preferred15+ years of regulatory affairs experience in the biotech or pharmaceutical industries, with emphasis on drug developmentPossess in-depth knowledge of global regulatory requirements and guidelines, including FDA, and EMA regulations and international regulatory frameworksProven track record of successful regulatory submissions, including INDs, NDAs, BLAs and MAAsExperience leading regulatory affairs strategies for complex programs across multiple therapeutic areasStrong understanding of drug development processes, CMC, quality, and clinical trial regulationsDemonstrated ability to navigate complex regulatory landscapes and anticipate and mitigate potential regulatory risksFamiliarity with radiopharmaceuticals is a plus Personal Attributes Foster a culture of excellence, collaboration, and continuous learningProactive, detail-oriented, and eager to learnComfortable working in a fast-paced biotech environmentTeam player who thrives on collaboration and cross-functional flexibilityCommitment to safety and continuous improvement What We Offer A unique chance to contribute to first-in-class cancer therapiesExposure to both radiochemistry and CMC development in a dynamic biotech settingHands-on training and professional development opportunitiesAn international, collaborative, and supportive work cultureCompetitive 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 company is shaped by a long-standing scientific legacy with nearly a century of pioneering work in radiation therapy conducted at the University of Oslo and Norway’s Radium Hospital. Cancer is relentless. So are we. 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. As an emerging, global biotech with locations in Boston, Basel, London, and Oslo, we take advantage of diverse scientific depth and insights, which makes ARTBIO a unique place to work. 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. Questions and Application Process If interested, please apply and send your CV to HR@artbio.com. All inquiries are treated confidentially. ARTBIO does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between ARTBIO and the agency. ARTBIO will not pay any fees related to unsolicited resumes.