Associate Director, Regulatory Affairs Project Planning & Coordination

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 Affairs Project Planning & Coordination is responsible for developing, implementing, and monitoring project plans and best practices that facilitate how the Global Regulatory Affairs department executes its strategic and functional goals. This role will create best practices that maximize the efficiency and impact in which Global Regulatory Affairs develops, endorses, and executes regulatory strategy. This role will also be involved in planning of regulatory submission timelines, compliance and maintenance activities, and department conduct.

Primary Responsibilities

• Develop and maintain integrated regulatory project plans for global submissions, health authority interactions, and key regulatory activities
  
  
• Establish and oversee a comprehensive Health Authority commitment tracker across Acadia's pre and postapproval portfolio
  
  
• Coordinate governance processes and the cadence of regulatory strategy reviews and endorsements with the Global Regulatory Affairs Leadership Team
  
  
• Design, implement, and maintain regulatory dashboards and scorecards to enable visibility, risk identification, and proactive planning
  
  
• Develop and manage a clinical trial public disclosure tracker and lead periodic crossfunctional status reviews
  
  
• Support Global Regulatory Affairs Leadership Team and Regulatory Project Teams with meeting planning, materials, and biannual inperson meeting coordination
  
  
• Partner with R&D initiative leaders to ensure regulatory alignment and track regulatory deliverables against development and corporate objectives
  
  
• Support the preparation, maintenance, and review of documentation supporting regulatory development and marketing applications, including SOP review
  
  
• Other duties as assigned
  
  

Education/Experience/Skills

• Bachelor's degree in life science, healthcare, or related field.
• Minimum of 8 years of regulatory drug development experience within the pharmaceutical or related industry
  
  
• Demonstrated experience supporting global regulatory submissions and health authority interactions
  
  
• Willingness and ability to travel domestically and internationally
  
  

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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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 $154,000—$193,000 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 ourReasonable Accommodation Request Formor contact us View email address on click.appcast.io.

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 within 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 Serbiawithin 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.