Associate Director, Regulatory Operations

The posting, as Acadia Pharmaceuticals Inc. wrote it

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 Associate Director, Regulatory Operations provides leadership for global regulatory submissions, regulatory information management, document management, and related technology. This role leads regulatory submission planning and delivery for assigned development and marketed products, serves as a subject matter expert for electronic document management, publishing, and Regulatory Information Management systems. The Associate Director partners with Regulatory Affairs and other cross-functional stakeholders, including external service providers to maintain compliant, efficient, inspection-ready processes and systems. The position operates with a high degree of independence, resolves complex operational and technical issues, and drives continuous improvement through governance, metrics, data quality, automation, and emerging technology.

Primary Responsibilities

Regulatory Submission Operations

• Lead and oversee the planning, preparation, formatting, assembly, publishing, quality control, dispatch, and archiving of global regulatory submissions and correspondence
• Coordinate submission deliverables for applications and lifecycle activities, including INDs, CTAs, NDAs, MAAs, amendments, supplements, health authority responses, and briefing documents
• Provide tactical guidance to global regulatory teams, translate regulatory strategy into executable operational plans, and identify and mitigate submission risks
• Interpret and apply current electronic submission standards, health authority technical requirements, internal policies, and operating procedures
• Serve as a point of escalation for submission, publishing, document, process, and technology issues; drive timely resolution with internal teams, IT and vendors
• Maintain complete, traceable, accurate, and readily retrievable regulatory records to support inspection readiness

Regulatory Information and Document Management

• Provide business ownership and operational leadership for assigned RIM and electronic document management capabilities, including registrations, submissions, submission archives, document met

[…]
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.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents with in our Privacy Policy.

Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.

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.