The Role
Leads regulatory strategy, health authority interactions, and submission execution for clinical-stage radiopharmaceutical programs. Coordinates INDs, CTAs, amendments, annual reports, meeting packages, information requests, and lifecycle submissions. Partners with clinical, medical, CMC, quality, nonclinical, and operations teams to develop compliant content, resolve data gaps, manage publishing, and maintain submission plans, records, calendars, and archives.
Summary Generated by Built In
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 Authorities.
- Translates program regulatory strategy into clear interaction plans, submission plans, timelines, and cross-functional deliverables for ARTBIO’s clinical-stage radiopharmaceutical programs.
- Leads the preparation, coordination, and delivery of regulatory submissions, including INDs, IND amendments, annual reports, meeting requests, CTAs, and other lifecycle submissions.
- Schedules and coordinates meeting rehearsals prior to Health Authority interactions.
- Finalizes meeting minutes with Health Authorities, responses to information requests, and follow-up actions.
- Oversees publishing and submissions.
- Partners with Clinical, Medical, CMC, Quality, Nonclinical, Clinical Operations, and other contributors to develop content, resolve data gaps, and maintain an aligned submission narrative.
- Maintains clear records of correspondences, commitments, decisions, and submission history.
- Establishes 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 preferred.
- 12+ 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 oncology.
- Strong knowledge of US FDA requirements and interaction processes
- Proven track record coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests.
- Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors.
- Experience 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 skills.
- Highly organized, proactive, and detail-oriented, with disciplined follow-through on commitments and timelines.
- Comfortable working in a fast-paced biotech environment with evolving priorities and multiple stakeholders.
- Collaborative leader who can align subject matter experts, challenge constructively, and drive decisions without losing momentum.
- Commitment to quality, compliance, and patient safety.
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 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 [email protected]. 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.
Skills Required
- Bachelor's degree in a scientific, medical, pharmacy, or related discipline
- 12+ years of progressive regulatory affairs experience in the biotech or pharmaceutical industry
- Leadership experience supporting regulatory interactions from pre-IND through Phase 3 investigational-stage programs in oncology
- Strong knowledge of US FDA requirements and interaction processes
- Experience coordinating US INDs, IND amendments, annual reports, health authority meeting packages, and responses to US FDA information requests
- Hands-on experience with electronic submission publishing, document management, submission standards, and external publishing vendors
- Advanced degree
- Experience submitting New Drug Applications and Marketing Authorization Applications
- Experience with radiopharmaceutical development
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The Company
What We Do
ARTBIO is a clinical-stage radiopharmaceutical biotechnology company focused on developing a new class of alpha radioligand therapies (ART). Our unique patient-centric approach is underpinned by a deep understanding of cancer biology and the infrastructure needed to effectively design, manufacture, and distribute our therapies.
