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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1