Sr. Director, Regulatory Affairs, Technology & Transformation
Acadia Pharmaceuticals Inc. · Princeton, New Jersey, United States; San Diego, California, United States; South San Francisco, California, United States · $220.6k–$275.7k
Posted by Acadia Pharmaceuticals Inc. on their careers site · View the original posting
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About Acadia Pharmaceuticals
Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference.
Please note that this position can be based in San Diego, CA, San Francisco, CA, or Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.
Position Summary
The Sr. Director, Regulatory Affairs, Technology & Transformation is a strategic role within Regulatory Operations responsible for defining and executing the technology, data, training, and transformation agenda for Global Regulatory Affairs. The role modernizes regulatory processes and capabilities through fit-for-purpose platforms, digitization, automation, analytics, artificial intelligence, structured content, and innovative ways of working. This leader connects business strategy with operational execution, ensuring solutions are compliant, scalable, adopted by users, and focused on measurable improvements in quality, speed, transparency, and organizational effectiveness.
Primary Responsibilities
- Develop and execute Regulatory Technology and Transformation strategy aligned with Global Regulatory Affairs objectives, corporate pillars, portfolio needs, and regulatory requirements
- Establish governance, prioritization, investment, and value-realization frameworks for technology and transformation initiatives, with clear roadmaps, ownership, dependencies, risks, and success measures
- Serve as a trusted advisor to Regulatory and senior enterprise leaders on capability priorities, emerging technologies, organizational readiness, and sustainable operating-model change. Identify, evaluate, prioritize, and responsibly implement opportunities involving AI, advanced analytics, automation, digital authoring, structured content, and decision-support capabilities
- Provide business leadership for the effective deployment, advancement, integration, validation, maintenance, training and adoption of regulatory information and document management capabilities, including RIM, DMS, publishing, submission, archiving, commitment tracking, and reporting solutions
- Partner with IT, Quality, Regulatory Operations, and business stakeholders to define user requirements, select and implement systems, manage upgrades and change controls, and maintain compliant, inspection-ready solutions. Advance interoperable regulatory data and content capabilities, including structured content, knowledg
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m, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com or 858-261-2923 .
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
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Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.