Associate Director, Regulatory Affairs

Role: Associate Director of Regulatory Affairs, focusing on global regulatory strategy for autoimmune biopharmaceuticals, primarily in the US market. Responsibilities include developing and executing regulatory plans, serving as the primary FDA contact, preparing IND/BLA/NDA dossiers, ensuring compliance, and managing interactions with regulatory authorities. The role involves providing strategic input for clinical study design, monitoring regulatory landscape changes, and collaborating cross-functionally with medical, legal, quality, and PV teams to facilitate product development and commercialization. Requirements: minimum 8 years of regulatory experience within biopharma, with 3-5 years in global leadership roles, preferably with a PhD or PharmD, strong expertise in FDA regulations, and experience with orphan drugs. Desired skills include strong interaction with regulatory agencies, strategic planning, project management, and knowledge of digital health technologies. High-value specifics: focus on autoimmune therapies, immunology, early to late-stage development, and a mix of pre-approval and post-approval activities. Collaboration spans multiple internal functions and external agencies, with a global regulatory perspective. Work setup is not specified, but the position is based in the US and involves high-level regulatory leadership.