SummaryThe 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.
Questions and Application ProcessIf 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. 
