Senior Director, Regulatory Affairs

Summary The Senior Director, Regulatory Affairs leads and coordinates regulatory interactions and submission execution for ARTBIO’s clinical-stage radiopharmaceutical programs. This role is primarily responsible for coordinating regulatory medical writing across functions. The position works cross-functionally to translate research and development data and strategy into clear, compliant regulatory communications and high-quality submission deliverables. Key Responsibilities Serves as the point of contact for Health AuthoritiesTranslates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programsLeads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissionsSchedules and coordinates meeting rehearsals prior to Health Authority interactionsFinalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actionsOversees publishing and submissionsPartners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrativeMaintains clear records of correspondences, commitments, decisions, and submission historyEstablishes and maintains regulatory plans, workflows, submission calendars, trackers, and archives Qualifications & Education Bachelor’s degree in a scientific, medical, pharmacy, or related discipline is required; an advanced degree is preferred12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry, including demonstrating leadership in leading the deliverables for regulatory interactions supporting pre-IND to Phase 3 investigational-stage programs in oncologyStrong knowledge of US FDA requirements and interaction processesProven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requestsHands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendorsExperience and familiarity with leading submission of New Drug Applications, Marketing Authorization Applications, and radiopharmaceutical development are helpful Personal Attributes Clear, concise communicator with strong scientific judgment and exceptional writing and editing skillsHighly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelinesComfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholdersCollaborative leader who can align subject matter experts, challenge constructively, and drive decisions without losing momentumCommitment to quality, compliance, and patient safety 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.