Acadia Pharmaceuticals Inc. · 2 hours ago
Regulatory Affairs Associate Operations
Princeton, New Jersey, United States
Full-time
Hybrid
Entry Level
$80K/yr - $100K/yr
3+ years expAcadia Pharmaceuticals is dedicated to innovative advancements in neurological and rare diseases. The Regulatory Affairs Associate Operations will handle eCTD submissions and document management to ensure compliance with health authority guidelines and best practices.
BiotechnologyHealth CarePharmaceutical
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
Qualification
Required
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
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
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
Company
Acadia Pharmaceuticals Inc.
Acadia Pharmaceuticals develops and commercializes small molecule drugs for the treatment of central nervous system disorders.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$811.73MKey Investors
National Institute of Neurological Disorders and StrokeOxford Bioscience PartnersNational Institute of Mental Health
2019-09-17Post Ipo Equity· $287.5M
2018-11-30Post Ipo Equity· $316.25M
2013-01-02Post Ipo Equity· $86.39M
Leadership Team
Catherine Adams
Chief Executive Officer
Steve Davis
President and CEO
Recent News
Company data provided by crunchbase