Senior Manager, Regulatory Affairs – Operations
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Job Description
Senior regulatory operations manager leading eCTD publishing and submission readiness for Telix Pharmaceuticals’ precision-medicine radiopharmaceutical portfolio. Driving docuBridge adoption, compliance, and operational improvements.
Responsibilities:
- Lead and oversee regulatory publishing operations across the product portfolio
- Ensure submission timelines, quality standards, and regulatory requirements are met
- Implement, roll out, support, and continuously optimize the Lorenz docuBridge publishing platform
- Develop best practices, training materials, and user support processes
- Establish and monitor KPIs and operational metrics for submission readiness, publishing quality, inspection preparedness, and departmental efficiency
- Provide leadership and mentorship to regulatory operations staff and cross-functional stakeholders
- Serve as a subject matter expert for electronic publishing, submission validation, and Health Authority gateway requirements
- Lead cross-functional process improvement initiatives
- Support vendor relationships and publishing service providers
- Partner with Regulatory Affairs leadership on strategic planning, resource forecasting, and submission prioritization
- Champion inspection readiness and compliance
- Maintain awareness of industry trends, evolving regulations, and global e-submission best practices
- Participate in maintenance activities for RIMS and EDMS, including Veeva Submission and Archive Vaults
- Refine procedures, standards, templates, and style guides for submission documents
- Facilitate Health Authority portal submissions, administer internal RA SOW/PO systems, and generate leadership metric reports
Requirements:
- Bachelor's degree or equivalent experience is required
- 8+ years of experience in Regulatory Affairs Operations
- 3-5+ years of leadership, people management, or functional leadership experience
- Experience supporting global regulatory submissions, including FDA, EMA, Health Canada, and MHRA
- Experience preparing, formatting, QCing, and finalizing regulatory documents for eCTD submissions, such as NDAs and/or EU Marketing Authorization Applications
- Strong organizational skills and ability to manage multiple projects and deadlines
- Excellent attention to detail and accuracy in documentation
- Expert knowledge of CTD/eCTD structure
- Knowledge and awareness of the Lorenz docuBridge publishing platform, with aptitude to learn and use it effectively
- Experience with MS Word, Adobe Acrobat, electronic publishing software, and document management systems such as CSC Toolbox and Veeva Collaborative Authoring or equivalent
- Strong project management skills and ability to assess and advise on project timeline impacts
- Outstanding written and verbal communication skills
- Ability to work independently in a remote setting across multiple time zones and effectively collaborate in a team environment
- General understanding of dossier Life Cycle Management is desired
- Fluent in English; additional European language is an asset
Benefits:
- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
- Hybrid and remote work arrangements
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