Sr. Specialist, Regulatory Affairs (Operations)

See Yourself at Telix

The Sr. Specialist, Regulatory Affairs Operations will play a key role in supporting global regulatory activities across Telix development programs. This role will focus on regulatory submission planning, execution, and lifecycle management, working closely with Regulatory Affairs Operations and Strategic leadership and cross-functional teams to ensure high-quality, timely regulatory submissions. 

This is a hands-on role requiring strong organizational skills, attention to detail, and the ability to manage projects and regulatory deliverables in a fast-paced biotech environment. The Sr. Specialist will help drive operational excellence across regulatory processes, systems, and submission planning while supporting global regulatory strategies for company programs. 

Key Accountabilities:

• 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. 

Education and Experience:

• 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. 

Key Capabilities:

• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills