Associate Director, Regulatory Affairs- Europe
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 supports informing regional and global strategic plans and helps build a European regulatory infrastructure that is fit for purpose in line with Acadia’s product pipeline, patient and caregiver needs, and 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.
* Coordinate planning, authoring, and finalization of major regulatory components of Marketing and Extension Applications, Renewals, and Variations.
* Plan and coordinate health authority meetings, including preparation and authoring of major components of briefing documentation in 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 alignment with Regulatory strategy and corporate goals.
* Maintain appropriate communication within the Regulatory Affairs function and other cross-functional departments at the project team level.
* Participate in professional associations, industry and trade groups to stay current on regulatory developments and apply knowledge to assigned programs.
* Other duties as assigned.
Education/Experience/Skills
Bachelor’s or Master’s degree in a related field. Targeting 8 years of relevant drug development experience, including regulatory affairs in the EU. Ph.D., Pharm.D., or M.D. with 5 years of relevant drug development experience, including regulatory affairs 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 across multiple projects in a cross-geographic and cross-functional matrix team environment.
* Critical, strategic thinking and independent problem-solving ability.
* Excellent written and verbal communication and 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 and alignment with Acadia values.
* Ability to travel domestically and internationally.
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 coverage
* 401(k) Plan with a fully vested company match 1:1 up to 5%
* Employee Stock Purchase Plan with a 2-year purchase price lock-in
* 15+ vacation days
* 13-15 paid holidays, including office closure between December 24th and January 1st
* 10 days of paid sick time
* Paid parental leave benefit
* Tution assistance
EEO Statement
Acadia is an equal employment opportunity employer. We are committed to building a diverse, equitable, inclusive, and innovative company. We encourage applications from candidates with diverse backgrounds and experiences. We provide reasonable accommodations to applicants with disabilities and veterans as requested. For accommodation requests, contact talentacquisition@acadia-pharm.com or 858-261-2923.
#J-18808-Ljbffr