Associate Director, Regulatory Affairs
The Associate Director of Regulatory Affairs is responsible for helping build and execute on global regulatory strategy, objectives, policies and programs pertaining to development and marketing of Acadia products, including the regulatory compliance for advertising and promotion of marketed products.
This role will also assist Sr. Regulatory Affairs Dept. Staff in the compilation of regulatory documentation to support US and ex-US regulatory development and marketing application submissions in compliance with corresponding regulations.
Regulatory Development and Life Cycle Management
- Provides regulatory strategic direction and support for assigned global development programs/development program activities and assists Sr. Regulatory Affairs staff with their development program activities and deliverables
- Designs and implements regulatory strategies with Regulatory Affairs staff to obtain and maintain product investigative and marketing applications for assigned programs, as well as their life cycle management
- Strong competency in understanding regulatory requirements and emerging regulatory landscapes associated with US and global regulatory authorities
- Experienced in responding to inquiries from global regulatory authorities as well as the preparation and conduct of meetings with global regulatory authorities intended to further the development of ACADIA development
- With limited oversight, interacts effectively with cross functional project team members in order to communicate regulatory objectives/strategies for regulatory deliverables, including ensure timely, high-quality and content appropriateness of documentation supporting regulatory submissions, ensuring departmental timelines are
Regulatory Submission Coordination
- Helps in establishment and execution of operational objectives of assigned and Staff projects
- Assists in the preparation and maintenance of Annual Reports, Development Safety Update Reports (DSURs), Investigator’s Brochures and other documents required for INDs, CTAs, NDAs and other related regulatory development and marketing applications
- Assists in the cataloging and maintenance of regulatory application submissions and
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
- Reviews SOPs pertaining to Regulatory
- Keeps abreast of regulatory procedures and changes
- Science or healthcare related degree preferred, including BS, MS, MPH, PharmD, PhD or MD. An equivalent combination of relevant education and applicable job experience may be considered
- Minimum of 8 years of experience in the pharmaceutical or related industry; regulatory drug development experience is required
- Ability to read, analyze and interpret scientific and technical information, as well as regulatory
- Ability to understand and explain detailed regulatory affairs and compliance programs and/or
- Ability to effectively present information to senior regulatory management, other departments or external
- Ability to comply with changing regulatory
- Ability to adapt to changing priorities and prioritize work
- Other duties as assigned
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. Employee must occasionally lift and/or move up to 15 pounds.
What we offer you:
- 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: 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 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.