Senior Director, Regulatory Operations

Position Summary

Lead and scale the global Regulatory Operations function, including organizational design, talent strategy, and performance management aligned to business and regulatory objectives.

Primary Responsibilities

• 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.

Education/Experience/Skills

• 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

Physical Requirements

• Regular standing, walking, sitting, and the use of hands for handling or operating equipment
• Reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations
• Occasionally lift and/or move up to 20 pounds
• The ability to travel independently overnight and/or work after hours as required by travel schedules or business needs

What we offer US-based Employees

• 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

EEO Statement (US-based Employees)

We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way.

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Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia

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