Associate Director, Regulatory Affairs

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, Regulatory Affairs based in the United States .

The Associate Director, Regulatory Affairs will support and lead global regulatory activities for an innovative oncology therapeutic throughout its clinical development and commercialization preparation. This role combines scientific expertise, regulatory strategy, and cross-functional leadership to ensure submissions meet the requirements of health authorities worldwide. The successful candidate will manage regulatory activities across assigned clinical studies, including IND and CTA submissions, regulatory timelines, agency interactions, and dossier development. Working closely with clinical, scientific, and regulatory stakeholders, this professional will help shape regulatory strategies and ensure accurate, consistent documentation. The position also involves direct engagement with the FDA and other health authorities, as well as contributions to future BLA and MAA filings. This is an opportunity to make a meaningful contribution to the development of investigational oncology therapies addressing significant unmet medical needs.