Senior Director, Regulatory Operations

Primary Responsibilities Lead and scale global Regulatory Operations (organizational design, talent strategy, performance management). Provide strategic oversight of electronic submission publishing, regulatory information management, and submission management across global health authorities. Direct worldwide eCTD and non-eCTD electronic submissions to ensure compliance with health authority, ICH, and global standards. Evaluate, implement, and optimize regulatory systems/tools (including Veeva Vault RIM and publishing platforms) to ensure validated, compliant, scalable solutions. Champion digital transformation in Regulatory Affairs, including AI/advanced analytics to improve submission readiness and operational insights. Partner with IT/Quality/cross‑functional teams to define requirements, manage validation/upgrades, and support evolving regulatory needs. Establish work instructions, training, and quality control for submission accuracy, consistency, and inspection readiness. Ensure compliance with technical standards (eCTD, CDISC, SEND) and lead adoption of best practices. Qualifications/Experience/Skills Bachelor’s degree in life sciences or related field. 12+ years progressively responsible Regulatory Operations/Regulatory Affairs experience. 8+ years leadership experience in electronic submissions, regulatory systems, and submission management. Hands‑on expertise with regulatory information management and publishing systems (Veeva Vault RIM, eCTD tools). Experience with validated regulatory systems and understanding of the software development lifecycle. Willingness and ability to travel domestically and internationally. Benefits/Compensation Discretionary bonus and equity awards; salary range $220,600–$275,700 USD. Medical, dental, and vision insurance; 401(k) 1:1 match up to 5%; employee stock purchase plan; 15+ vacation days; paid holidays and sick time; paid parental leave; tuition assistance. #J-18808-Ljbffr