FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Senior Specialist, Regulatory Affairs – Operations
Telix Pharmaceuticals LimitedSr. Specialist in Regulatory Affairs supporting global regulatory activities for Telix Pharmaceuticals.
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Support the planning, coordination, and execution of global regulatory submissions, including INDs, CTAs, BLAs, NDAs, MAAs, and amendments, ensuring compliance with global regulatory requirements and timelines.
- This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities.
- Maintain regulatory documentation, submission records, and regulatory information within regulatory systems and document management platforms.
- Oversee regulatory document management, tracking, and archival activities.
- Support regulatory systems (e.g., Veeva RIM), and serve as internal subject matter expert (SME) for training and support to internal stakeholders.
- Coordinate regulatory submission activities including document readiness, publishing, quality control, and electronic submission (eCTD) processes.
- Support preparation and operational coordination of regulatory agency interactions, including briefing document planning and submission logistics.
- Monitor and track submission deliverables and milestones, identifying risks and proactively working with stakeholders to mitigate potential delays.
- Ensure compliance with global regulatory submission standards, including eCTD structure, formatting, and publishing requirements.
- Contribute to the development and implementation of regulatory operations processes, tools, and best practices to improve efficiency and consistency across programs.
- Support lifecycle management activities, including post-approval submissions, amendments, annual reports, and regulatory correspondence.
Requirements
What you’ll need- Bachelor’s degree in Life Sciences or a related discipline is required.
- Minimum of 5 years of relevant experience in Regulatory Affairs or Regulatory Operations within the pharmaceutical or biotechnology industry.
- Experience with Regulatory Information Management Systems (RIMS), Electronic Document Management Systems (EDMS), and electronic publishing tools; experience with Veeva Vault Regulatory is required.
- Strong working knowledge of the drug development process and global regulatory frameworks.
- Experience coordinating with and/or overseeing external publishing service providers for regulatory submissions is desirable.
- Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) and collaboration tools such as Microsoft Teams.
- Experience using project planning and tracking tools (e.g., Smartsheet, Microsoft Project, or similar) to support regulatory timelines and deliverables.
- Knowledge of global regulatory submission standards and requirements, including FDA, EMA, ICH guidelines, and eCTD submission formats.
- Demonstrated experience compiling, validating, and submitting regulatory dossiers in eCTD format.
- Experience with CTD/eCTD structure, format, and submission requirements, and proficiency in MS Word (e.g., authoring templates), Adobe Acrobat, electronic publishing software, and document management systems (e.g., CSC Toolbox, Lorenz DocuBridge, or equivalent); advanced or expert-level knowledge is an advantage.
- Strong organizational, communication, and project management skills, with the ability to manage multiple priorities simultaneously and assess the impact of changes on project timelines.
- Ability to work effectively in a collaborative, fast-paced, mid-size company environment.
- Fluency in English (spoken, written, and reading); proficiency in an additional European language is an asset.
Benefits
Comp & perks- Competitive salaries
- Annual performance-based bonuses
- Equity-based incentive program
- Generous vacation
- Paid wellness days
- Support for learning and development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionseCTDregulatory information management systemselectronic document management systemsregulatory operationsdrug development processregulatory dossiersCTD structureproject planningdocument management
Soft Skills
organizational skillscommunication skillsproject management skillscollaborationability to manage multiple prioritiesrisk identificationoperational oversighttrainingstakeholder engagementproblem-solving