Associate Director Regulatory Affairs Europe

Acadia Pharmaceuticals is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world.

The Associate Director, Regulatory Affairs Europe is responsible for the implementation and execution of global regulatory development, submission and lifecycle maintenance strategies for assigned products in Europe. The role will inform regional and global strategic plans on a continuous basis, build a European regulatory infrastructure, and ensure compliance with European regulatory requirements and standards.

• Proactively initiate, manage, submit and maintain regulatory activities in support of the development, commercialization and maintenance of assigned products in compliance with reporting requirements.
• Plan, coordinate and manage Pediatric Investigation Plans and Orphan Designations.
• Plan, coordinate, author and finalize major regulatory components of Marketing Authorization Applications, Extensions, Renewals and Variations; coordinate health authority meetings and prepare briefing documentation in close collaboration with cross‑functional teams.
• Develop regulatory strategy for assigned products in line with the global regulatory strategy to ensure competitive labeling and approval timelines in Europe (through centralised, decentralised or national procedures).
• Lead the European Regulatory Subteam during major submissions.
• Monitor, evaluate, and interpret applicable regulatory requirements to assure compliance with external and internal standards.
• Support early access/compassionate use programs in Europe.
• Execute team, group, or project objectives to ensure alignment with Regulatory strategy and corporate goals.
• Maintain appropriate communication within the Regulatory Affairs function and other cross‑functional departments at the project team level.
• Participate in professional associations, industry and trade groups to keep current on regulatory developments and apply knowledge to assigned programs.
• Work with growing independence under the direction of supervisor.

• B.S. or M.S. with 7 years of relevant drug development experience, including 5 years relevant regulatory affairs experience in the EU.
• Ph.D., Pharm.
  
  D., or M.D. with 5 years relevant drug development experience, including 3 years regulatory affairs experience in the EU.

• Proven track record of successfully leading major submission components (e.g., Module1 of an MAA) in Europe.
• Effective regulatory project management: preparation, coordination, submission and maintenance of regulatory applications.
• Ability to coordinate deliverables using effective time management across multiple projects in a cross‑geographic and cross‑functional matrix team environment.
• Strong analytical, strategic, independent thinking and problem‑solving skills with an inclination to innovate.
• Excellent written and verbal communication skills, demonstrative strong presentation skills, strong regulatory and scientific writing skills.
• Strong interpersonal and teamwork skills.
• Strong interest in staying abreast of scientific and regulatory standards and procedures.
• High level of motivation, drive, and demonstration of Acadia values.
• Willing and able to travel both domestically and internationally as needed.

The Acadia policy states that women and people of color are less likely to apply for jobs unless they believe they meet every qualification exactly as described. We are committed to building a diverse, equitable, inclusive, and innovative company and encourage applications from individuals who may have less traditional backgrounds or meet the qualifications in different ways. Acadia provides equal employment opportunities to all employees and applicants without regard to race, religion, gender, sexual orientation, gender identity, national origin, citizenship, age, disability, veteran status, or any protected class as defined by federal, state, or local law.