Associate Director Regulatory Affairs Europe

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• 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 including 3 years regulatory affairs experience in the EU.
• Proven track record of successfully leading major submission components (e.g. Module 1 of a 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.
• Ability to think critically, strategically, independently and solve problems, include the ability to innovate.
• Excellent written and verbal communication skills, demonstrative strong presentation skills.
• Strong interpersonal and teamwork skills.
• Strong regulatory/ scientific writing skills.
• Strong interest to stay abreast of scientific and regulatory standards and procedures.
• High level of motivation, drive, and demonstration of Acadia values.
• Must be willing an able to travel both domestically and internationally as needed.