Regulatory Document Specialist, Regulatory Affairs

Role Summary

The Regulatory Document Specialist will have primary responsibility for document management activities supporting Regulatory Affairs within Spyre. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management, along with other assigned tasks. This role position will play an integral role in the execution of the Regulatory strategy worldwide, with multiple avenues for continued development within the Regulatory Operations function.

Responsibilities

• Document Level Responsibilities:
  • Provide ongoing Word formatting support and final formatting for internally authored documents intended for submission.
  • Perform final PDF publishing for all submission documents.
  • Ensure that all final electronic deliverables meet current regulatory electronic document requirements.
  • Assess publishing and formatting needs and communicate impacts to overall project timelines.
  • Assist in managing the activities of external publishing staff contracted to publish and dispatch health authority submissions.
  • Manage document-related tasks including internal workflow management, file transfer, tracking, and archival.
  • Communicate and provide deliverables to Medical Writers, Quality, Regulatory Leads and others as applicable.
  • Initiate preliminary drafts of documents for team authoring activities, as needed.
• Submission Level Responsibilities:
  • Manage submission archival for ongoing regulatory submissions.
  • Maintain and update trackers, correspondence logs, and metrics, as needed, to support the Regulatory Team.
  • File Regulatory correspondence in the Regulatory Information Management (RIM) system.
  • Collaborate with cross-functional teams to ensure regulatory compliance and submission timelines.
• Infrastructure Level Responsibilities:
  • Assist in Veeva RIM management activities.
  • Serve as the internal subject matter expert (SME) for Accenture Formatting Tool, as a resource for Regulatory and cross-functional authoring teams.
  • Assist in maintaining regulatory document template library.
  • Lead training sessions on submission formatting, new systems and tools, etc.

Qualifications

• Required: Bachelor‚Äôs degree with a minimum of 3-5+ years of experience in a Regulatory Operations environment within the pharmaceutical industry, preferably with a focus on eCTD dossier management. In lieu of a degree, 6+ years of relevant industry experience is required.
• Required: Proven experience managing multiple active regulatory applications simultaneously.
• Required: Advanced proficiency with Microsoft Office Suite and Adobe.
• Required: Demonstrates adaptability, a strong willingness to learn new skills, and a collaborative approach to supporting team initiatives.
• Preferred: Experience with Veeva RIM systems and SharePoint.
• Required: Attention to detail, and excellent organizational and prioritization skills.
• Required: Motivated to work in a fast-paced, high-accountability environment.
• Required: Excellent communication and interpersonal skills, with the ability to motivate teams and collaborate effectively across functions.

Skills

• Regulatory document formatting and publishing
• eCTD dossier management
• Document workflow management and archival
• Veeva RIM (experience preferred)
• Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe
• Cross-functional collaboration and stakeholder communication

Education

• Bachelor‚Äôs degree in a related field (or equivalent experience)