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. Accountabilities: - 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.
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