Senior Director, Regulatory Operations

Senior Director, Regulatory Operations

This position is based in Princeton, NJ, South San Francisco, CA or San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Position Summary

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.

Primary 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

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

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to 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. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

Salary Range

$220,600$275,700 USD

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): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. 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. We strongly encourage you to apply, especially if the reason you are the best candidate isn't exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.