Manager, Regulatory Affairs (Operations)

Key Accountabilities

• Collaborate with teams to guide the regulatory requirements and expectations for preparing compliant submission documents, including managing the document workflows for timely deliverables.
• Align and work within submission plans, effectively managing submission document preparation deadlines across product portfolio, coordinating activities between relevant functions.
• Stay current on industry trends relevant to global electronic submissions as it relates to document preparation for eCTD submission.
• Participate, as needed for the maintenance activities of the Regulatory Information Management Systems (RIMS) and EDMS (e.g. Veeva Submission and Archive Vaults).
• Understand the eCTD publishing systems (e.g., Lorenz docuBridge) and publish-readiness requirements as defined by the industry and company.
• Develop and manage the document preparation process through the utilization of templates and internal style guides to ensure both QC and formatting standardizations.
• Collaborate to support and enhance the regulatory operations document infrastructure through the continuous refinement of appropriate procedures, standards, templates, and style guides related to authoring, formatting, reviewing, and publishing of submission documents.
• Provide guidance on document-related best practices and regulatory requirements to internal teams and troubleshoot and/or train as needed.
• Be committed to process improvement for efficiencies across business practices as it relates to preparing Telix's documents for Regulatory submission both establishing (where needed) and upholding excellent quality standards.
• Assist Regulatory Operations management with administrative and compliance tasks, including facilitating Health Authority portal submissions, overseeing internal RA SOW/PO system administration, and generating metric reports for leadership.

Position Requirements

• Bachelor's degree or equivalent experience is required
• 7+ years of experience in Regulatory Affairs Operations required
• Preferred experience with US/Canada and/or European regulatory legislation and procedures required
• Demonstrated experience in preparing documents for submission: Formatting, QCing, submission-ready preparation and finalization of regulatory document for eCTD submission (e.g., New Drug Applications (NDA) and/or EU Marketing Authorization Applications)
• Strong organizational skills with an ability to manage multiple projects and deadlines
• Excellent attention to detail and accuracy in documentation
• Expert knowledge of CTD/eCTD structure (e.g., Lorenz docuBridge), format, and submission requirements
• Experience with MS Word (e.g., Authoring Templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g. CSC Toolbox and Veeva Collaborative Authoring or equivalent)
• Strong project management skills; a keen attention to detail; and to assess and advise teams on potential impact or changes in project timelines
• Outstanding written and verbal communication skills, including the ability to communicate effectively with internal colleagues at various levels, and with external vendor partners
• Self-motivated and results-oriented with an enthusiastic attitude and the ability to work independently in a remote setting in multiple time zones where needed as well as build relationships and work effectively in a team environment
• General understanding of dossier Life Cycle Management is desired
• Fluent in English (speaking, reading, and writing), any additional European language is an asset