Manager Regulatory Strategy
Job Description
Please note that this position is based in San Diego, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.
The Manager, Regulatory Affairs position is responsible for implementing global regulatory strategies and submissions for product(s) in the assigned development teams. This role will assist Senior Regulatory Affairs department staff in the development of regulatory strategy and compilation of documentation to support US and global regulatory submissions for clinical trials and marketing applications
Primary Responsibilities
- Initiate, manage, and maintain regulatory activities in support of clinical trial and marketing applications working with cross-functional teams.
- Monitor, evaluate, and interpret applicable regulatory requirements to assure compliance with external and internal standards.
- Coordinate clinical trial transparency postings.
- Execute team, group, or project objectives to ensure they align with Regulatory strategy and corporate goals.
- Maintain appropriate communication within the RA function and other cross-functional departments primarily at the project team level.
- 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, applying knowledge to assigned programs.
- Works with growing independence under the direction of supervisor.
- Other duties as assigned.
Education/Experience/Skills
Bachelor's degree in a life science or related field. Targeting 2 years of experience in US Regulatory Affairs, with additional global experience preferred. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Ability to coordinate deliverables using time management across multiple projects in a matrix team environment
- Excellent written and verbal communication and ability to present concisely
- Strong interpersonal and teamwork skills
- Strong knowledge of different functional document types that comprise eCTD regulatory submissions including clinical documents and other reports.
- Keep abreast and analyze of submission and data standards, regulatory policies, procedures, security standards, GMP, and GCP.
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 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business needs.
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In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.
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 or contact us at or .
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 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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