EU Regulatory Affairs Director, Europe: Strategy & Submissions

ACADIA Pharmaceuticals Inc.; Baar; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Competitive compensation

Health insurance

Life & disability insurance

401(k) match

Employee stock purchase plan

Vacation days

Paid holidays

Sick leave

Parental leave

Tuition assistance

Zusammenfassung

Acadia Pharmaceuticals Inc. is seeking an Associate Director, Regulatory Affairs Europe to drive regulatory development, submission and lifecycle strategies across Europe. The role involves coordinating ECG/Pediatric plans, leading major EU submissions and ensuring compliance with European requirements.

The ideal candidate has extensive EU regulatory experience, strong writing skills, and the ability to work across cross-functional teams while travel may be required.

Qualifikationen

• Minimum 7 years drug development experience with 5+ years regulatory affairs in the EU.
• Strong track record in leading major EU submissions (e.g., Module 1 of MAA).
• Excellent regulatory/scientific writing and communication skills.

Aufgaben

• Proactively initiate, manage, submit and maintain regulatory activities in Europe.
• Plan and coordinate Pediatric Investigation Plans and designations.
• Lead major regulatory submission components and subteams in Europe.

Kenntnisse

Regulatory leadership EU

Regulatory project management

Cross-functional collaboration

Strategic thinking

Technical writing

Effective communication

Ausbildung

B.S./M.S. with EU regulatory exp

Ph.D./Pharm.D./M.D. with EU reg exp

Jobbeschreibung

Acadia Pharmaceuticals Inc. is seeking an Associate Director, Regulatory Affairs Europe to drive regulatory development, submission and lifecycle strategies across Europe. The role involves coordinating ECG/Pediatric plans, leading major EU submissions and ensuring compliance with European requirements.

The ideal candidate has extensive EU regulatory experience, strong writing skills, and the ability to work across cross-functional teams while travel may be required.