European Regulatory Strategy Lead

Arbeitnow; Zug; Hybrid; CHF 160.000 - 230.000; Vollzeit

Benefits dieser Stelle

Competitive base salary

Bonus program

Equity plan

Zusammenfassung

Acadia Pharmaceuticals is seeking an Associate Director, Regulatory Affairs Europe to drive regulatory development, submission, and lifecycle management strategies for EU products. This role shapes European regulatory infrastructure in line with Acadia’s pipeline and compliance with EU standards.

The candidate will lead major submissions, coordinate health authority interactions, and ensure alignment with global regulatory strategies while traveling as needed.

Qualifikationen

• BS or MS with 7 years in drug development and 5 years EU regulatory affairs.
• PhD/PharmD/MD with 5 years drug development and 3 years EU regulatory affairs.
• Proven track record leading MAAs/module 1 in Europe.
• Strong regulatory writing and project management skills.
• Ability to work across cross-functional teams and travel.

Aufgaben

• Lead regulatory activities for EU products ensuring compliance.
• Plan Pediatric Investigation Plans and Orphan Designations.
• Coordinate major regulatory submissions (Module 1, Renewals, Variations).
• Prepare briefing documents for health authority meetings.
• Develop EU regulatory strategy aligned with global plans.
• Lead European Regulatory Subteam during major submissions.
• Monitor regulatory developments and ensure compliance.

Kenntnisse

Regulatory affairs

Project management

Regulatory strategy

Regulatory writing

Cross-functional

Communication skills

Ausbildung

BS/MS in life sciences

PhD/PharmD/MD in life sciences

Jobbeschreibung

Acadia Pharmaceuticals is seeking an Associate Director, Regulatory Affairs Europe to drive regulatory development, submission, and lifecycle management strategies for EU products. This role shapes European regulatory infrastructure in line with Acadia’s pipeline and compliance with EU standards.

The candidate will lead major submissions, coordinate health authority interactions, and ensure alignment with global regulatory strategies while traveling as needed.