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 Acadia’s product pipeline, patient and caregiver needs and in full compliance with European regulatory requirements and standards.

• 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.

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.

• 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…