Senior Manager, Regulatory Affairs (Operations)

See Yourself at Telix

Senior Manager, Regulatory Affairs (Operations) is responsible for the management, organization, and delivery of regulatory submissions and submission-ready documents at Telix, ensuring efficient, compliant, and high-quality document workflows across departments. The Senior Manager provides leadership and expertise in the preparation of regulatory submission documents and dossiers, while coordinating and overseeing document formatting, publishing, and finalization through submission readiness with exceptional attention to detail.

This role is responsible for driving operational excellence through the effective use of regulatory operations tools and processes to ensure document standards meet company, industry, and regulatory agency requirements. In addition, the Senior Manager leads the successful rollout, adoption, and ongoing utilization of the Lorenz DocuBridge publishing platform, establishing best practices and supporting cross-functional teams to optimize publishing efficiency and submission quality. The ideal candidate facilitates multiple workstreams, drives continuous process improvements, and delivers results within tight deadlines

Key Accountabilities:

• Lead and oversee regulatory publishing operations across the product portfolio, ensuring submission timelines, quality standards, and regulatory requirements are consistently met.
• Drive the successful implementation, rollout, adoption, and continuous optimization of the Lorenz docuBridge publishing platform, including development of best practices, training materials, and user support processes.
• Establish and monitor key performance indicators (KPIs) and operational metrics to measure submission readiness, publishing quality, inspection preparedness, and departmental efficiency.
• Provide leadership and mentorship to regulatory operations staff and cross-functional stakeholders, fostering knowledge sharing and operational excellence.
• Serve as one of the primary subject matter expert for electronic publishing, submission validation, and Health Authority gateway requirements, ensuring compliance with global regulatory standards.
• Lead cross-functional initiatives to identify, implement, and sustain process improvements that enhance regulatory submission quality, efficiency, and scalability.
• Support Associate Director with vendor relationships and publishing service providers, as applicable, ensuring deliverables meet quality, timeline, and budget expectations.
• Partner with Regulatory Affairs leadership to support strategic planning, resource forecasting, and prioritization of submission activities across development and marketed product programs.
• Champion inspection-readiness and compliance by ensuring documentation, records, and submission processes adhere to internal policies and global regulatory expectations.
• Stay current with industry trends, evolving regulations, and best practices related to global electronic submissions and eCTD document preparation.
• 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-ready-readiness requirements as defined by the industry and company.
• 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.
• 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

Education and Experience:

• Bachelor's degree or equivalent experience is required
• 8+ years of experience in Regulatory Affairs Operations required. 3-5+ years of leadership, people management, or functional leadership experience. Preferred experience supporting global regulatory submissions (FDA, EMA, Health Canada, MHRA, etc.
• 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 / Knowledge and awareness of the Lorenz docuBridge publishing platform with the aptitude and technical capability to quickly learn, adopt, and effectively utilize the system to support regulatory publishing activities.
• 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.
• Aptitude for enjoying working with colleagues from different functions and locations and cultures; reaching out proactively, seeking the answer, engaging the team where needed.
• Fluent in English (speaking, reading, and writing), any additional European language is an asset.

Key Capabilities:

• 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
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to 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
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills