Director Regulatory Strategy @ Acadia Pharmaceuticals Inc.

Please note that this position is based in Princeton, NJ. Acadia’s hybrid model requires this role to work in our office three days per week on average.

The Director Regulatory Affairs position is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned development teams. Continually expands therapeutic are and disease state knowledge. Ensures strategic messaging and content of global regulatory dossiers. Serves as primary regulatory interface with health authorities. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Serves as resource to team members for the regulatory requirements, processes, and logistics to conduct global drug development activities for compounds from the preclinical stage through approval, initial marketing, and life cycle management. Demonstrates excellent understanding of drug development and leadership behaviors consistent with the level. Provides leadership and acts as a resource to the broader regulatory function, including peer mentorship of junior staff.

Primary Responsibilities

Interfaces with cross-functional teams to lead and support company objectives. Leads the regulatory project team to development of creative global strategies in line with applicable regulations to achieve business objectives for development and/or marketed products.
Leads cross-functional stakeholders to ensure appropriate and clear strategic messaging in global regulatory dossiers and responses to requests from health authorities.
Key internal leader and driver of regulatory policy and strategy for assigned products
Leads preparation of global regulatory product strategies for assigned products. Leads regulatory and cross-functional team in the preparation and maintenance of risk assessment and mitigation strategies and communicates plans to relevant stakeholders.
Proactively researches and presents regulatory assessments and recommendations.
Makes decisions regarding work processes or operational plans and schedules to achieve the program objectives.
Maintains compliance with reporting requirements for existing applications (IND, NDA, MAA). Prepares and submits all maintenance submissions.
Participates in professional associations, industry, and trade groups to keep current on regulatory intelligence and applying knowledge to assigned programs.
Works independently under the direction of supervisor.

Education/Experience/Skills

Bachelor’s degree in a life science or related field.
Targeting 10 years progressively responsible experience, with 5 years in a leadership role.
Experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Canada, or Japan.
Strong global development foundation with business acumen.
An equivalent combination of relevant education and experience may be considered.

Key Qualifications:

Strong knowledge of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports.
Experience in supporting global clinical trial applications via CROs (e.g. CTIS).
Ability to communicate clearly and concisely, both in writing & verbally, with others in a professional manner.
Keep abreast and analyze of submission and data standards, regulatory policies, procedures, security standards, GMP, and GCP.
Ability to work cross-functionally to solve complex business process and technical problems, escalating concerns to senior management as appropriate.
Ability to schedule team priorities with minimal supervision.
Ability to work efficiently in a fast-paced environment where priorities change frequently to meet the business needs.

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 15 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.

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What we offer you (US-Based Employees):

Competitive base, bonus, new hire and ongoing equity packages
Medical, dental, and vision insurance
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
14 paid holidays plus one floating holiday of your choice, including office closure between December 24th and January 1st
10 days of paid sick time
Paid parental leave
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 single 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 would strongly encourage you to apply – especially if the reason you are the best candidate isn’t exactly as we describe it 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 accommodation given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

Notice for California Applicants: Please see our California Applicant Privacy Notice 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 absence of an executed search agreement will not obligate Acadia in any way with the 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.