Head of Regulatory Affairs

ARTBIO • Cambridge, MA

2d

About The Position

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.

Requirements

• 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.

Nice To Haves

• Familiarity with radiopharmaceuticals is a plus.

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.

Benefits

• Competitive compensation and benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior