Executive Director, Regulatory Operations
About The Position
The Executive Director, Regulatory Operations provides enterprise-wide strategic leadership for global regulatory operations, regulatory information management, submission technologies, and regulatory business process excellence. As a senior leader within Global Regulatory Affairs, this role is responsible for defining and executing the long-term vision for regulatory operations, advancing digital transformation and AI-enabled capabilities, and ensuring scalable infrastructure to support Acadia's global development and commercial portfolio. The Executive Director serves as a key strategic partner to executive leadership across Regulatory Affairs, IT, Quality, Development, and Commercial organizations to drive operational excellence, compliance, inspection readiness, and organizational effectiveness.
Requirements
- Bachelor's degree in life sciences or related field; advanced degree preferred (MS, PharmD, PhD, MBA).
- Minimum 15+ years of progressively responsible experience in Regulatory Operations, Regulatory Affairs, or related functions.
- Minimum 12+ years of people leadership experience, including leadership of leaders and global teams.
- Demonstrated experience shaping global regulatory operations strategy for late-stage development and commercial products.
- Proven track record leading large-scale digital transformation, regulatory technology, and process optimization initiatives.
- Experience presenting to executive leadership and influencing enterprise-level decisions.
- Strong understanding of global regulatory frameworks, health authority requirements, and industry trends.
- Experience managing significant budgets, vendor partnerships, and global operating models.
Responsibilities
- Develop and execute the global Regulatory Operations strategy aligned with Acadia's corporate and portfolio objectives.
- Serve as a senior member of the Global Regulatory Affairs leadership team, influencing cross-functional and enterprise-wide strategic decisions.
- Lead global regulatory operations, regulatory technology, and information management capabilities across development and commercial programs.
- Establish long-term roadmaps for regulatory systems, automation, AI, data governance, and digital innovation.
- Represent Regulatory Operations in executive governance forums and strategic planning discussions.
- Drive organizational design, succession planning, leadership development, and talent strategies for a high-performing global Regulatory Operations organization.
- Provide executive oversight for health authority submission readiness, inspection preparedness, and regulatory compliance activities.
- Build and maintain relationships with key external partners, vendors, industry groups, and regulatory agencies as appropriate.
- Lead due diligence and integration activities related to business development, partnerships, acquisitions, and portfolio expansion.
- Oversee regulatory operations budgets, resource planning, vendor strategy, and investment prioritization.
- 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
Executive
