Associate Director Regulatory Affairs Europe

About the role

The Associate Director, Regulatory Affairs Europe is responsible for the implementation and execution of global regulatory development, submission and lifecycle maintenance strategies for assigned products in Europe. The role involves informing regional and global strategic plans while building a European regulatory infrastructure that aligns with the company's product pipeline and patient needs.

Responsibilities

• Proactively initiate, manage, submit and maintain regulatory activities in support of the development, commercialization and maintenance of assigned products.
• Plan, coordinate and manage Pediatric Investigation Plans and Orphan Designations.
• Lead the planning, coordination, authoring and finalisation of major regulatory components of Marketing and Extension Applications, Renewals and Variations.
• Plan and coordinate health authority meetings including the preparation and authoring of major components of briefing documentation.
• Develop regulatory strategy for assigned products in line with the global regulatory strategy ensuring competitive labeling and approval timelines in Europe.
• Lead the European Regulatory Subteam during major submissions.
• Monitor, evaluate, and interpret applicable regulatory requirements to assure compliance with external and internal standards.
• Support early access and compassionate use programs in Europe.

Required skills

• Regulatory Affairs
• Regulatory strategy
• Regulatory project management
• Regulatory writing
• Scientific writing
• MAA submission

Qualifications

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

About the Company

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Their commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.