EU Regulatory Affairs Lead | Associate Director

Acadia Pharmaceuticals; Zug; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) Plan with match

Zusammenfassung

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Europe to lead regulatory development, submission and lifecycle maintenance for products in Europe. The role requires experience in EU regulatory strategy, cross-functional collaboration, and managing major submission components.

The successful candidate will drive regulatory planning, support pediatric and orphan designation processes, and ensure compliance with European standards across projects in a dynamic pipeline.

Qualifikationen

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

Aufgaben

• Proactively initiate, manage, submit and maintain regulatory activities for European products.
• Plan, coordinate and manage Pediatric Investigation Plans and Orphan Designations.

Kenntnisse

Regulatory strategy

Regulatory project management

跨 borders collaboration

Ausbildung

Bachelor/Master in life sciences

PhD/MD/PharmD with EU regulatory exp.

Jobbeschreibung

Acadia Pharmaceuticals is seeking an Associate Director of Regulatory Affairs Europe to lead regulatory development, submission and lifecycle maintenance for products in Europe. The role requires experience in EU regulatory strategy, cross-functional collaboration, and managing major submission components.

The successful candidate will drive regulatory planning, support pediatric and orphan designation processes, and ensure compliance with European standards across projects in a dynamic pipeline.