Manager, Regulatory Operations, Publishing
Job Description
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years 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 FDA-approved drug 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 neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.
Position Summary
The Regulatory Operations Manager is responsible for publishing, QC, and transmittal of eCTD submissions,. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions in alignment with health authority guidelines and industry best practices. This individual will have a clear understanding of electronic submission requirements including the eCTD structure, Word templates and styles.
Primary Responsibilities
- Using Acadia's eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions in alignment with health authority guidelines and industry best practices.
- For authored documents, provide guidance on formatting and review for adherence to Acadia's Style Guide
- Perform document verifications and follow procedures to identify, document, and communicate findings
- Manage document management tasks including file transfer, storage, tracking, and archival services
- Provide training to cross functional teams on Acadia style guide and Acadia authoring templates.
- Validate and QC published eCTD submissions, working collaboratively with teammates to resolve findings and issues
- Support authors and contributors providing guidance on electronic document requirements to be included in regulatory submissions
- Utilize Electronic Submission Gateway (ESG) to transmit submissions to FDA and other Health Authorities
- Update trackers, correspondence logs, metrics on daily/weekly/monthly basis as internal policies dictate
- Other activities as designated
Education/Experience/Skills
Requires a Bachelor's degree in Business Administration, Life Science discipline or related field. Targeting 5 years of experience in Regulatory Affairs Operations or relevant function. An equivalent combination of relevant education and experience may be considered.
Key Skills:
- Working knowledge of eCTD guidance (e.g., ICH, FDA, EMA, etc.), requirements, and technologies
- Knowledge, understanding, and experience with Veeva VAULT RIM authoring workflows, document metadata, and naming conventions
- Strong working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Word, Acrobat, DXC Toolbox, authoring templates)
- Ability to work collaboratively with Regulatory Affairs, Medical Writing, and other functions to publish regulatory submissions and support management of documents and reports
- Demonstrated ability to effectively communicate in written and verbal media concepts related to regulatory systems and electronic submissions
- Ability to deliver while working under pressure to meet tight deadlines
Scope
Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
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.
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 Reasonable Accommodation Request Form or contact us at talentacquisition@acadia-pharm.com 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.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity
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