[Hiring] Senior Manager, Regulatory Affairs (Operations) @AMER

Role Description

The 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.

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.

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.
• 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.
• Serve as a primary subject matter expert for electronic publishing, submission validation, and Health Authority gateway requirements.
• 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.
• Partner with Regulatory Affairs leadership to support strategic planning, resource forecasting, and prioritization of submission activities.
• Champion inspection-readiness and compliance by ensuring documentation adheres 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 in maintenance activities of the Regulatory Information Management Systems (RIMS) and EDMS.
• Collaborate to support and enhance the regulatory operations document infrastructure.
• Assist Regulatory Operations management with administrative and compliance tasks.

Qualifications

• 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.
• Demonstrated experience in preparing documents for submission.
• 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 of the Lorenz DocuBridge publishing platform.
• Experience with MS Word, Adobe Acrobat, electronic publishing software, and document management systems.
• Strong project management skills.
• Outstanding written and verbal communication skills.
• Self-motivated and results-oriented.
• General understanding of dossier Life Cycle Management is desired.
• Fluent in English; any additional European language is an asset.

Requirements

• Commitment to excellence.
• Results-oriented.
• Creativity and innovation.
• Strong communication skills.
• Collaboration.
• Resilience.
• Inclusive mindset.
• Adaptability.
• Ethical behavior.
• Continuous learning.