Regulatory Affairs Director, Europe

Acadia Job Listings; Zug; Ibrido; CHF 150.000 - 210.000; Tempo pieno

Vantaggi offerti da questo lavoro

Competitive base and bonus

Equity/stock options

Medical, dental, vision insurance

Life and disability coverage

401(k) plan with company match

Descrizione del lavoro

Acadia Pharmaceuticals Inc. seeks an Associate Director, Regulatory Affairs Europe to lead regulatory development, submission, and lifecycle activities for European programs.

You will shape regulatory strategy, collaborate with global teams, and ensure EU compliance across centralized, decentralised, and national procedures. You will coordinate Pediatric Investigation Plans, Orphan Designations, and major submissions while guiding the European Regulatory Subteam.

Competenze

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

Mansioni

• Proactively initiate, manage, submit and maintain regulatory activities in Europe.
• Plan and coordinate Pediatric Investigation Plans and Orphan Designations.
• Coordinate major regulatory components of Marketing/Extension Applications, Renewals and Variations.
• Prepare briefing documents for health authority meetings with cross-functional teams.
• Develop regulatory strategy aligning with global plans and timelines in Europe.
• Lead the European Regulatory Subteam during major submissions.
• Monitor regulatory requirements to ensure compliance with standards.
• Support early access/compassionate use programs in Europe.
• Communicate across Regulatory and other cross-functional teams.

Conoscenze

Regulatory strategy

Regulatory project management

Cross-functional collaboration

Strategic thinking

Regulatory writing

Communication skills

Travel flexibility

Formazione

B.S./M.S. in a relevant field

Ph.D./Pharm.D./M.D. with EU regulatory experience

Descrizione del lavoro

Acadia Pharmaceuticals Inc. seeks an Associate Director, Regulatory Affairs Europe to lead regulatory development, submission, and lifecycle activities for European programs.

You will shape regulatory strategy, collaborate with global teams, and ensure EU compliance across centralized, decentralised, and national procedures. You will coordinate Pediatric Investigation Plans, Orphan Designations, and major submissions while guiding the European Regulatory Subteam.