Head of Regulatory Affairs

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Define and spearhead the global regulatory strategy for ARTBIO’s clinical-stage radiopharmaceutical initiatives.

• Oversee essential regulatory submissions such as INDs, CTAs, and DMFs.

• Direct interactions with the FDA and global health authorities, including preparation for meetings, briefing documents, responses, and follow-up actions.

• Ensure adherence to regulatory standards throughout the drug development lifecycle, encompassing clinical trials and manufacturing processes.

• Proactively detect potential regulatory challenges and create mitigation strategies.

• Recognize regulatory risks and provide counsel to executive leadership regarding timelines and key decision points.

• Collaborate with Clinical, CMC, Quality, Nonclinical, Clinical Development and Operations, regulatory consultants, and external publishing partners to ensure timely and high-quality submissions.

• Act as the main liaison for regulatory agencies, fostering strong relationships with key regulatory authorities.

• Stay informed on regulatory policy changes and offer practical guidance to internal teams concerning requirements, risks, and opportunities.

• Enhance regulatory capabilities through team leadership, mentoring, training, and robust cross-functional collaboration.

⛳️ Requirements

• 15+ years of experience in regulatory affairs within the biotech or pharmaceutical sectors, focusing on drug development.

• Comprehensive understanding of global regulatory requirements and guidelines, including FDA and EMA regulations along with international regulatory frameworks.

• Proven success in regulatory submissions, including INDs, NDAs, BLAs, and MAAs.

• Experience in leading regulatory affairs strategies for complex programs across various therapeutic areas.

• Strong grasp of drug development processes, CMC, quality, and clinical trial regulations.

• Demonstrated capability to navigate intricate regulatory environments and foresee and mitigate potential regulatory risks.

• Knowledge of radiopharmaceuticals is advantageous.

• An advanced degree (JD, PhD, PharmD, MD, or equivalent) in a scientific field is preferred.

• Proactive, detail-oriented, and enthusiastic about learning.

• Comfortable operating in a fast-paced biotech environment.

• A team player who excels in collaboration and cross-functional adaptability.

• Commitment to safety and ongoing improvement.

🏝️ Benefits

• A distinctive opportunity to contribute to pioneering cancer therapies.

• Exposure to both radiochemistry and CMC development within a dynamic biotech environment.

• Practical training and professional development opportunities.

• An international, collaborative, and supportive workplace culture.

• Competitive salary and benefits package.