Head of Regulatory Affairs

Your Impact

Alpha-9 Oncology is seeking a dynamic and experienced Executive Director/Vice President of Regulatory Affairs to lead regulatory strategies for our groundbreaking radiopharmaceutical therapies. This pivotal role will focus on advancing innovative approaches that integrate targeted radiation with precision medicine, driving clinical development and regulatory approvals. Partnering closely with cross-functional teams, including CMC, clinical, quality, and discovery, you will shape strategies that directly impact patient outcomes, ensuring compliance with regulatory requirements while advancing our mission of transforming cancer care.

This is an opportunity to shape the future of Alpha-9 Oncology’s radiopharmaceutical therapies, influencing both corporate strategy and the advancement of groundbreaking treatments.

This role is based in our Boston office with flexibility for hybrid work.

What You’ll Do

• Develop and execute global regulatory strategies to support clinical development, registration, and lifecycle management of radiopharmaceuticals and imaging agents.
• Lead regulatory interactions with agencies such as the FDA, EMA, and other global authorities, including pre-IND, IND, BLA, and MAA filings.
• Integrate imaging dosimetry and therapeutic insights into regulatory planning to optimize clinical trial success and product differentiation.
• Oversee the preparation and submission of regulatory documents, ensuring alignment with ICH, FDA, and EMA guidelines.
• Establish processes to ensure adherence to GMP, GLP, and other compliance standards across radiopharmaceutical development.
• Partner with CMC, clinical, and quality teams to drive efficient regulatory processes, including managing CDMO relationships for radiolabeling and drug manufacturing.
• Contribute to the design of imaging and therapeutic studies, ensuring their integration into the regulatory roadmap.
• Build and lead a high-performing regulatory affairs team, fostering a collaborative and innovative environment.
• Provide mentorship and professional development opportunities to team members.

What You Bring

• Advanced degree (PhD, PharmD, MD, or equivalent) in life sciences, pharmacy, or related discipline.
• At least 12 years of regulatory affairs experience, with 5+ years in a senior leadership role, preferably within oncology or radiopharmaceutical development.
• Deep expertise in oncology drug development and global regulatory pathways, with preferred experience in radiopharmaceuticals and PET/SPECT imaging agents.
• Proven success in leading interactions with global health authorities and achieving regulatory milestones.
• Expertise in GMP, GLP, and ICH guidelines, as well as experience managing INDs, CTAs, NDAs, or MAAs.
• Exceptional leadership, communication, and strategic thinking skills, with the ability to work effectively in a fast-paced and innovative environment.
• Travel up to 25%.

What's in it for you

At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.

Company Summary

Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.

Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.

More about Alpha-9 Oncology

Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.

We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.