Associate Director, Regulatory Affairs Project Planning & Coordination

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 post-approval portfolio
• Cook up and oversee 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 cross-functional status reviews
• Support Global Regulatory Affairs Leadership Team and Regulatory Project Teams with meeting planning, materials, and bi-annual in-person 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

• Regular standing, walking, sitting, and the use of hands for handling or operating equipment
• 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
• Occasionally lift and/or move up to 20 pounds
• Able to travel independently overnight and/or work after hours as required by travel schedules or business needs

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)

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.

Additional Information for California Residents

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Additional Information for Canadian Residents

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Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia

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