Associate Director, Regulatory Operations

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 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 metadata records lifecycle management dictionaries and user administration Lead and support system governance and administrative processes including access management user training and experience issue management configuration change control release management validation documentation and ongoing operational support Partner with stakeholders to gather and translate business requirements into scalable system and process solutions Ensure regulatory information documents and records are managed in accordance with applicable regulations company procedures and validated-system requirements

Technology Validation and Continuous Improvement

Partner with Information Technology Quality other business owners and vendors on system implementations upgrades integrations validation and operational support Support validation activities including user needs requirements risk assessment test planning test script authoring and execution defect resolution and release readiness Evaluate evolving regulations industry practices system capabilities artificial intelligence automation and emerging technologies recommend and implement fit-for-purpose improvements and participate in industry forums and represent Acadia at relevant conferences/events Lead process optimization and system configuration initiatives that improve quality compliance efficiency usability and transparency Develop and maintain SOPs work instructions standards templates checklists governance documents and training materials

Business Partnership

Act as a trusted Regulatory Operations advisor to global regulatory teams and cross-functional partners Lead cross-functional initiatives and taskforces influence decisions and promote consistent global practices without relying on formal authority Oversee external vendors consultants and contractors including scope quality timelines performance and budget responsibilities May oversee and develop junior personnel and project team members as assigned Other responsibilities as assigned

Education/Experience/Skills

Bachelor’s degree in scientific discipline or related field. An equivalent combination of relevant education and experience may be considered Targeting 8 years of regulatory operations experience within the pharmaceutical or biotech industry Must have strong expertise in the eCTD process oversight of electronic document management systems and publishing software and tools Must have technical expertise in EDMS oversight Thorough knowledge of US and international regulations as they apply to Regulatory Affairs Operations Ability to influence and partner cross-functionally Self-organized self-directing and highly motivated critical thinking and analytical skills Demonstrated ability to contribute to a continuous learning and process improvement environment Excellent verbal and written organizational and communication skills Willingness and ability to travel domestically and internationally as needed

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 $146,000 $182,500 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.