Regulatory Affairs Associate Operations

Acadia Pharmaceuticals Inc.•Princeton, NJ

3d•$80,000 - $100,000•Hybrid

About The Position

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. 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 Regulatory Operations Associate is responsible for publishing, QC, and transmittal of eCTD submissions, as well as document formatting and report-level publishing. This role will use eCTD publishing and document management systems to compile high-quality, technically valid submissions and reports in alignment with health authority guidelines and industry best practices.

Requirements

Bachelor’s degree in a life science, information technology, business administration or a related field.
Targeting 3 years of progressively responsible experience in regulatory operations or relevant function, preferably in a pharmaceutical or biotech environment.
An equivalent combination of relevant education and experience may be considered.
Thorough working knowledge of eCTD guidances (e.g., ICH, FDA, EMA, etc.), requirements, and technologies.
Experience in vendor selection, configuration, and implementation of regulatory information management systems and publishing systems.
Demonstrated ability to work collaboratively with IT, QA, and vendors to develop, implement, and maintain regulatory systems.
Working knowledge of tools and technologies related to document formatting/document-level publishing (e.g., Acrobat, DXC Toolbox, authoring templates).
Understanding of computer system validation principles and change control processes.
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 manage multiple priorities and work cross-functionally in a fast-paced environment.
Must be able and willing to travel on occasion.

Responsibilities

Using Acadia’s eCTD publishing (IQVIA RIM Smart) and document management (Veeva Vault RIM), publish eCTD submissions and reports in alignment with health authority guidelines and industry best practices.
For authored documents, ensure formatting is applied consistently according to Acadia’s Style Guide.
As needed, prepare PDF documents for inclusion in regulatory submissions by editing bookmarks, hyperlinks, and other elements to ensure submission-readiness.
QC published eCTD submissions and reports, working collaboratively with teammates to resolve findings and issues.
Support authors and contributors to documents/reports to be included in regulatory submissions by advising on use of Veeva Vault RIM.
For clinical study reports, deliver Regulatory Operations kickoff slides (covering use of Veeva Vault RIM and tracking of appendices).
For clinical study reports, work with SMEs/authors to track status of appendices and manage overall timelines for completion.
As needed, work with system business owners, IT, and QA to support system. implementations and updates including execution of validation scripts
Other responsibilities as assigned.

Benefits

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