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 United States. The Associate Director, Regulatory Affairs is a key member of a global regulatory organization, helping shape and execute regulatory strategies across the product lifecycle. You will serve as a trusted advisor and business partner, with a strong focus on US regulatory activities and FDA engagement. The role spans pre-approval, filing, launch, distribution, and post-approval activities for innovative medicines. You will work closely with clinical, medical, legal, quality, pharmacovigilance, and commercial teams to support critical business decisions. As a primary regulatory contact, you will lead agency interactions and contribute to high-quality submissions and responses. The position combines strategic thinking with hands-on execution in a fast-paced, science-driven environment. It offers the opportunity to influence regulatory strategy, support successful product launches, and contribute to medicines addressing significant patient needs.

Develop and implement robust US regulatory strategies for assigned development and commercial projects. Provide strategic, operational, and tactical regulatory guidance across pre-approval and post-approval activities, with a particular focus on the US and regional regulatory strategy. Serve as a primary point of contact with the FDA and lead or participate in regulatory meetings as appropriate. Prepare internal teams for interactions with regulatory authorities and ensure effective coordination of agency communications. Lead and oversee the preparation of regulatory dossier content for INDs, BLAs, and NDAs. Critically review submission documents to ensure quality, consistency, and compliance with applicable regulatory requirements. Coordinate timely responses to FDA questions in alignment with established product and regulatory strategies. Contribute to labeling development and regulatory negotiation strategies. Provide regulatory input into clinical development and study design. Partner closely with medical, legal, quality, pharmacovigilance, distribution, and other cross-functional teams to ensure regulatory considerations inform business decisions. Monitor, interpret, and communicate changes in the US regulatory environment, legislation, and guidance. Assess the competitive regulatory landscape, including regulatory precedents, labeling differences, and therapeutic-area-specific considerations. Leverage digital technologies, AI-enabled environments, data-driven insights, and innovative tools to strengthen regulatory strategy and cross-functional alignment. Support strategic planning, resource allocation, prioritization, and execution of complex regulatory initiatives in a matrix environment. Build strong relationships across functions and provide leadership that combines strategic direction with hands-on execution. Requirements Minimum 8 years of regulatory affairs experience within biopharmaceutical organizations, including 3–5 years in global leadership roles with a strong FDA focus. PhD or PharmD preferred. Experience working in rapidly growing pharmaceutical or biopharmaceutical organizations is desirable. Thorough understanding of the drug development lifecycle, with expertise in orphan drugs and knowledge of evolving global regulations and guidelines. Demonstrated experience coordinating critical regulatory documentation supporting the approval of medicines, particularly FDA-focused submissions. Proven experience interacting directly with regulatory authorities. Ability to engage effectively with scientists, clinicians, business leaders, and other stakeholders on technical and commercial topics. Strong understanding of current and emerging regulatory legislation, industry trends, and global healthcare business practices. Highly developed organizational and project management skills, including strategic planning, delegation, resource allocation, and workload prioritization. Strong communication and presentation capabilities, with the ability to influence stakeholders internally and externally. Ability to build collaborative relationships and connect teams around shared business and regulatory objectives. Comfortable operating in a fast-paced, results-oriented, highly accountable environment. Pragmatic, creative, and innovative approach, with a willingness to take a hands-on role in delivering results. Demonstrated leadership experience, including the ability to build, motivate, and develop teams. Strong strategic thinking combined with the ability to execute independently and through cross-functional teams. Familiarity with digital technologies, AI-enabled tools, and data-driven approaches to regulatory strategy is valued. Strong ability to navigate complex challenges, prioritize competing demands, and drive operational excellence. Benefits Annual base salary hiring range of $164,000–$225,500 USD , with individual compensation determined based on relevant experience, skills, demonstrated competencies, and internal equity. Eligibility to participate in short-term and long-term incentive programs , subject to applicable plan terms and policies. Comprehensive benefits package, including retirement savings plans and health benefits . Opportunity to work in a global, science-driven environment focused on advancing innovative medicines. Strategic exposure across the full product lifecycle, from development and regulatory submissions through commercialization and post-approval activities. Close collaboration with scientific, clinical, medical, legal, quality, pharmacovigilance, and business teams. Opportunity to influence US regulatory strategy and lead interactions with the FDA. Environment that values innovation, collaboration, accountability, and professional growth. Remote work arrangement within the United States.

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