Manager Regulatory Affairs Operations
Job title: Manager Regulatory Affairs Operations in San Diego, CA - Princeton, NJ at Acadia Pharmaceuticals
Company: Acadia Pharmaceuticals
Job description: Please note that this position can be based in San Diego, CA OR Princeton, NJ. Acadia's hybrid model requires this role to work in our office three days per week on average.Position SummaryThe Regulatory Affairs 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
- 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.
- Working knowledge of eCTD guidances (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