Head of Regulatory Affairs

Summary

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

EEO Statement

Questions and Application Process

Originally posted on Himalayas