SummaryThe 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 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 drug development.
- 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.
- Experience leading regulatory affairs strategies for complex programs across multiple therapeutic areas.
- 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.
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. 
