Head of Regulatory Affairs

Artbio•Cambridge, MA

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.
Fostering 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.

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.