Associate Director, Regulatory Affairs- Europe

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 Acadias 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 finalization 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 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 centralized decentralized or national procedures).

Lead the European Regulatory Sub team 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.

Other duties as assigned.

Education / Experience / Skills

Bachelors or Masters degree in a related field. Targeting 8 years of relevant drug development including regulatory affairs experience in the EU. Ph.D. Pharm. D. or M.D. with 5 years of relevant drug development including regulatory affairs experience in the EU. An equivalent combination of relevant education and experience may be considered.

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.

Excellent written and verbal communication skills excellent presentation skills.

Strong interpersonal and teamwork skills.

Strong regulatory / scientific writing skills.

Keep abreast of scientific and regulatory standards and procedures.

High level of motivation drive and demonstration of Acadia values.

Works with growing independence under the direction of immediate supervisor.

Ability to travel both domestically and internationally.

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Required Experience :

Director

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1