Associate Director Regulatory Affairs Europe

Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome.

We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs.

At Acadia, we’re here to be their difference.

</span></div></div><p><strong><u>Position Summary</u></strong></p> <p>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.

Staying abreast of the ever evolving regulatory and therapeutic landscapes, the Associate Director will inform regional and global strategic plans on a continuous basis.

Further, the Associate Director will assist in building a European regulatory infrastructure that is fit for purpose in line with Acadia’s product pipeline, patient and caregiver needs and in full compliance with European regulatory.

Requisitos

Primary

Responsabilidades

• Proactively initiate, manage, submit and maintain regulatory activities in support of the development, commercialization and maintenance of assigned products in compliance with reporting requirements.
• Plan, coordinate and manage Pediatric Investigation Plans and ...