Manager Regulatory Affairs Operations

Manager Regulatory Affairs Operations

Requirements

• 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.
• 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.

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.

Preferred Qualifications

No preferred qualifications provided.