Associate Director Regulatory Affairs Europe

Über diese Stelle

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. 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.

Position Summary

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 requirements and standards.

Primary Responsibilities

• 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 Orphan Designations.

• Responsible for the planning, coordination, authoring and finalisation of major regulatory components of Marketing and Extension Applications, Renewals and Variations

• Plan and coordinate heath authority meetings including the preparation and authoring of major components of briefing documentation in close collaboration with cross-functional teams.

• Develop regulatory strategy for assigned products in line with the global regulatory strategy ensuring competitive labeling and approval timelines in Europe (through centralised, decentralised or national procedures).

• 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/ compassionate use programs in Europe.

• Execute team, group, or project objectives to ensure they align with Regulatory strategy and corporate goals.

• Maintain appropriate communication within the Regulatory Affairs function and other cross-functional departments primarily at the project team level.

• Participates in professional associations, industry, and trade groups to keep current on regulatory developments, applying knowledge to assigned programs.

• Works with growing independence under the direction of supervisor.

• Other duties as assigned.

Education/Experience/Skills

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.

Key Skills:

• Proven track record of successfully leading major submission components (e.g. Module 1 of a MAA) in Europe.

• Effective regulatory project management (preparation, coordination, submission and maintenance of regulatory applications).

• Ability to coordinate deliverables using effective time management across multiple projects in a cross-geographic and cross-functional matrix team environment.

• Ability to think critically, strategically, independently and solve problems, include the ability to innovate.

• Excellent written and verbal communication skills, demonstrative strong presentation skills.

• Strong interpersonal and teamwork skills.

• Strong regulatory/ scientific writing skills.

• Strong interest to stay abreast of scientific and regulatory standards and procedures.

• High level of motivation, drive, and demonstration of Acadia values.

• Must be willing an able to travel both domestically and internationally as needed.

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What we offer US-based Employees:

• Competitive base, bonus, new hire and ongoing equity packages

• Medical, dental, and vision insurance

• Employer-paid life, disability, business travel and EAP…