Associate Director Regulatory Affairs Europe

Acadia Pharmaceuticals seeks an Associate Director of Regulatory Affairs Europe in Zug to lead regulatory strategy, submissions, and compliance for neurological and rare disease products.

The company is looking for a leader to drive the implementation of global regulatory strategies for its European portfolio. This role focuses on ensuring competitive approval timelines and building a robust regulatory infrastructure that aligns with the company’s pipeline and patient needs.

Responsibilities

• Oversee the full lifecycle of regulatory activities for assigned products within the European market, including initiation, management, and submission.
• Develop and execute regulatory strategies to secure favorable labeling and efficient approval schedules.
• Lead the European regulatory subteam during critical submission phases.
• Plan, coordinate, and author major components of Marketing Authorization Applications, renewals, and variations.
• Manage Pediatric Investigation Plans and secure Orphan Designations.
• Organize meetings with health authorities and prepare necessary briefing documents.
• Interpret and monitor evolving regulatory requirements to maintain full compliance.
• Provide support for early access and compassionate use programs across Europe.

Requirements

• A B.S. or M.S. degree combined with seven years of drug development experience, including five years in EU regulatory affairs.
• Alternatively, a Ph.D., Pharm. D., or M.D. with five years of drug development experience, including three years in EU regulatory affairs.
• Demonstrated success in leading major submission components, such as Module 1 of a Marketing Authorization Application.
• Strong project management capabilities within a regulatory context.
• Ability to manage time effectively across multiple projects in a cross-functional, global matrix environment.
• Excellent scientific and regulatory writing abilities.
• Superior verbal and written communication skills, including strong presentation capabilities.
• Willingness and ability to travel domestically and internationally as required.

About the company

Acadia Pharmaceuticals is dedicated to transforming scientific potential into meaningful innovations for communities affected by neurological and rare diseases. The company fosters a diverse, equitable, and inclusive culture while developing a robust pipeline of next-generation therapeutic advancements.

• Focus on creating meaningful innovation for underserved neurological and rare disease patients.
• Commitment to building a diverse, equitable, and inclusive workplace.
• Development of a robust pipeline aimed at next-wave therapeutic advancements.