Sr. Director, Regulatory Affairs, Technology & Transformation

yellow MessageBody About Acadia Pharmaceuticals / yellow 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.

center 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 knowledge management analytics workflow automation cloud-enabled submissions APIs and connectors and responsible AI/ML use cases Ensure regulatory platforms interface effectively with other relevant GxP and enterprise systems to enable secure efficient information exchange across Clinical Quality Technical Operations Commercial Program Management and related functions Lead the design digitization implementation and continuous improvement of end-to-end regulatory processes reducing manual effort cycle time rework and operational risk while improving predictability and user experience Oversee relevant policies SOPs work instructions standards job aids training and governance practices that support consistent compliant execution across regions and programs Use metrics analytics assessments and user feedback to identify improvement opportunities and demonstrate measurable business outcomes Lead organizational change management stakeholder engagement communications training and adoption strategies that embed new capabilities and ways of working Foster a culture of innovation continuous learning disciplined experimentation and accountability while ensuring innovation remains grounded in business needs and compliance expectations Monitor external regulatory technology trends evolving health authority expectations industry practices and peer networks to inform capability investments and strategic direction Communicate progress benefits risks decisions and lessons learned clearly to technical operational and executive audiences Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in life sciences information systems business engineering or a related field advanced degree preferred.;An equivalent combination of relevant education and experience may be considered Targeting 12 years of progressive experience in Regulatory Affairs Regulatory Operations regulatory technology or a comparable regulated life sciences function including significant leadership responsibility Demonstrated success developing and executing regulatory technology digital enablement analytics or enterprise transformation strategies that deliver measurable business outcomes Deep understanding of global regulatory processes regulatory content development submission management eCTD standards document and records management archiving health authority interactions and inspection-readiness expectations experience with Regulatory Information Management and Document Management platforms experience with Veeva RIM IQVIA SmartSolve Lorenz Docubridge or comparable enterprise regulatory platforms is highly valued Proven strategic and enterprise-minded with the ability to connect long-term regulatory capability strategy with practical execution and near-term business priorities. Experience leading regulated system implementations integrations upgrades validation change control business process design governance and lifecycle management in partnership with IT and Quality Active engagement in regulatory operations technology and industry forums with a strong external network and awareness of emerging practices Demonstrated experience with organizational change management stakeholder engagement training and adoption of new systems and processes across global cross-functional organizations and ability to lead complex change with disciplined governance clear outcomes and sustained adoption Proven people leadership including developing teams and managing employees contractors consultancies and distributed or remote resources Exceptional communication influence judgment and executive presence with the ability to translate complex business and technical issues into clear decisions and practical action Collaborative and influential to build alignment across Regulatory IT Quality and business functions without relying solely on formal authority Experience leading AI machine learning advanced analytics knowledge management workflow automation structured content or cloud-enabled regulatory submission initiatives Surfaces risks early makes sound decisions and follows through on commitments Balances innovation and speed with regulatory GxP security privacy and inspection-readiness expectations Willingness and ability to travel domestically and internationally as needed

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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.

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16px In addition to a competitive base salary this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience performance and location.

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.

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 a Reasonable Accommodation Request Form;or contact us at a talentacquisition@acadia-pharm.com;or a 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.