Senior Director, Regulatory Operations
About The Position
The Senior Director, Regulatory Operations provides strategic and operational leadership for global regulatory operations, overseeing electronic submissions, regulatory information management systems, and end‑to‑end submission execution. This role is a key member of the Global Regulatory Affairs Leadership Team and plays a critical role in driving operational excellence, scalability, compliance, and digital innovation across Regulatory Affairs. The position partners closely with Regulatory Affairs leadership, IT, Quality, and cross‑functional teams to ensure high‑quality, compliant, and timely submissions worldwide while advancing modern systems and emerging technologies, including AI.
Requirements
- Bachelor’s degree in life sciences or a related field
- Minimum of 12 years of progressively responsible experience in Regulatory Operations or Regulatory Affairs
- Minimum of 8 years of leadership experience with responsibility for electronic submissions, regulatory systems, and submission management
- Hands‑on expertise with regulatory information management and publishing systems, including Veeva Vault RIM and eCTD tools
- Experience overseeing validated regulatory systems and understanding of the software development lifecycle
- Willingness and ability to travel domestically and internationally
Responsibilities
- Lead and scale the global Regulatory Operations function, including organizational design, talent strategy, and performance management aligned to business and regulatory objectives
- 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 regulatory standards
- Drive evaluation, implementation, and optimization of regulatory systems and tools, including Veeva Vault RIM and publishing platforms, ensuring validated, compliant, and scalable solutions
- Champion digital transformation initiatives within Regulatory Affairs, including the application of AI and advanced analytics to enhance submission readiness and operational insights
- Partner with IT, Quality, and cross‑functional stakeholders to define system requirements, oversee validation, manage upgrades, and support evolving regulatory needs
- Establish and maintain work instructions, training programs, and quality control processes to ensure submission accuracy, consistency, and inspection readiness
- Ensure compliance with global regulatory technical standards, including eCTD, CDISC, and SEND, and lead adoption of evolving industry best practices
- Other duties as assigned
Benefits
- Competitive base, bonus, new hire and ongoing equity packages
- Medical, dental, and vision insurance
- Employer-paid life, disability, business travel and EAP coverage
- 401(k) Plan with a fully vested company match 1:1 up to 5%
- Employee Stock Purchase Plan with a 2-year purchase price lock-in
- 15+ vacation days
- 13 -15 paid holidays, including office closure between December 24th and January 1st
- 10 days of paid sick time
- Paid parental leave benefit
- Tuition assistance
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What This Job Offers
Job Type
Full-time
Career Level
Senior
