Job description
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visit Acadia.com and follow us on LinkedIn and X.
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 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
Bachelor’s or Master’s 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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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
- Tuition assistance
EEO Statement (US-based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.
It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.
As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia’s career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete our Reasonable Accommodation Request Form or contact us at [email protected] or 858-261-2923.
Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.
California Applicants: Please see Additional Information for California Residents within our Privacy Policy.
Canadian Applicants: Please seeAdditional Information for Canadian Residents within our Privacy Policy.
Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.
Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (“Acadia”). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia employees in the absence of an executed search agreement will not obligate Acadia in any way with respect to the future employment of those individuals or potential remuneration to any recruiter or search firm. Candidates should never be submitted directly to our hiring managers or employees.
