Head of Regulatory Affairs

ARTBIO; Cambridge (MA); On-site; USD 260,000 - 400,000; Full time

Job summary

ARTBIO is seeking a Head of Regulatory Affairs to lead the regulatory function for its clinical-stage radiopharmaceutical programs. You will shape strategy, oversee submissions, and engage with health authorities to ensure compliant execution across development and manufacturing.

The role requires 15+ years in biotech/pharma regulatory affairs, an advanced scientific degree, and a proven track record with INDs, NDAs, and MAAs.

Qualifications

• Advanced degree in a scientific discipline (JD, PhD, PharmD, MD or equivalent).
• 15+ years regulatory affairs experience in biotech/pharma with emphasis on drug development.
• In-depth knowledge of FDA, EMA and international regulatory frameworks.
• Proven track record of regulatory submissions (INDs, NDAs, BLAs, MAAs).
• Experience leading regulatory strategies for complex programs across multiple therapeutic areas.
• Strong understanding of drug development, CMC, quality, and clinical trial regulations.
• Familiarity with radiopharmaceuticals is a plus.

Responsibilities

• Define and lead global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical programs.
• Lead regulatory submissions, including INDs, CTAs, and DMFs.
• Lead FDA and global health authority interactions, including meeting preparation and follow-up actions.
• Ensure regulatory compliance across the drug development lifecycle, including trials and manufacturing.
• Identify regulatory risks and develop mitigation strategies.
• Partner with cross-functional teams to support timely, high-quality submissions.
• Serve as primary contact for regulatory agencies and build external relationships.

Skills

Regulatory leadership

Education

Advanced degree (JD/PhD/PharmD/MD)

Job description

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 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.

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 AlphaDirecttechnology, 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.