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. This is an opportunity to play a key role in advancing innovative therapies for patients with serious diseases within a clinical-stage biotechnology environment. You’ll contribute to global regulatory strategy and execution across the full product development lifecycle, with a strong focus on FDA interactions and submissions. The role offers meaningful exposure to oncology and rare disease programs, including complex regulatory pathways and multiple development phases. You’ll work closely with Clinical, Project, Study, and other cross-functional teams to translate regulatory requirements into practical development strategies. You’ll also support agency interactions, submission planning, regulatory operations, and external partners while helping manage risks and timelines. The position is suited to a strategic, detail-oriented regulatory professional who thrives in a collaborative, fast-moving, mission-driven setting. Your work will directly contribute to bringing potentially life-changing medicines from development toward patients who need them. Contribute to the development and execution of global regulatory strategies, providing actionable regulatory guidance to cross-functional teams and ensuring strategies evolve with changing regulatory and business requirements. Support end-to-end regulatory planning and execution for submissions, including INDs, NDAs, BLAs, briefing packages, and orphan drug applications. Serve as a regulatory liaison with the FDA and other global health authorities as assigned, supporting effective and well-prepared agency interactions. Prepare briefing materials and coordinate internal preparation for FDA and other health authority meetings, ensuring teams are aligned on objectives, messaging, and supporting documentation. Communicate regulatory risks, milestones, timelines, requirements, and strategic updates clearly to senior leadership, project teams, and external stakeholders. Represent Regulatory Affairs on Project, Clinical, and Study Teams, ensuring regulatory considerations remain aligned with broader development objectives. Help coordinate cross-functional regulatory submission teams and ensure high-quality, timely contributions from internal stakeholders, consultants, and external partners. Support the selection, management, and oversight of regulatory consultants, CROs, and other external vendors. Monitor regulatory intelligence, including changes to legislation, guidelines, regulatory expectations, and global health authority practices, and translate relevant developments into actionable recommendations. Develop, maintain, and improve regulatory SOPs, processes, and best practices to promote operational excellence and compliance. Ensure regulatory strategies and activities remain compliant with applicable regulations, guidance, and internal standards. Participate in regulatory due diligence and provide regulatory insights during business development and strategic evaluation activities. Apply AI tools effectively in day-to-day regulatory work to improve research, analysis, productivity, and operational efficiency. Requirements Bachelor’s degree in a scientific discipline or equivalent professional experience required; an advanced degree such as an MS, PhD, or PharmD is preferred. 7+ years of experience in the pharmaceutical or biotechnology industry, including at least 4 years in Regulatory Affairs. Demonstrated experience in oncology and across multiple stages of drug development. Proven experience preparing and supporting global regulatory submissions, particularly FDA NDA and BLA filings. Global regulatory experience and familiarity with international regulatory pathways are strongly preferred. Strong working knowledge of the drug development process, regulatory frameworks, guidelines, and the