Head of Regulatory Affairs

Alpha-9 Oncology•Boston, MA

2d•Hybrid

About The Position

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 with flexibility for hybrid work.

Requirements

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%.

Responsibilities

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.