Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.
See Yourself at Telix
The Senior Manager, Global Regulatory Strategy oversees regulatory activities for the assigned early-stage portfolio across global markets. Reporting to the VP, Global Regulatory Strategy, this individual-contributor role executes the global regulatory strategy for assigned assets, planning and delivering high-quality submissions from IND/CTA through to early registration. As a key contributor to the Regulatory Strategy team, the Senior Manager provides regulatory expertise for early-stage programs, prepares health authority interactions, and supports the VP on global regulatory planning and cross-functional initiatives that accelerate development.
Key Accountabilities:
Regulatory Strategy & Planning
- Contribute to and execute the global regulatory strategy for assigned early-stage assets, planning IND/CTA submissions in collaboration with cross-functional teams and under the direction of the VP, Global Regulatory Strategy.
- Develop submission plans, timelines, and content requirements for assigned programs, ensuring alignment with development milestones and corporate objectives.
- Support the development of registration strategies and manage the registration process for assigned early-stage assets in collaboration with cross-functional teams.
Health Authority Interactions
- Prepare briefing packages and supporting materials for health authority meetings on early-stage filings; draft meeting minutes and responses to agency questions with senior review.
- Interface with FDA, EMA, TGA, PMDA, and other health authorities for assigned filings, ensuring submissions meet regulatory requirements and deadlines.
Cross-Functional Collaboration
- Partner with QA, Clinical Development, Research & Innovation, and other functions to assemble compliant, on-time dossiers for assigned assets.
- Provide regulatory guidance to project teams on assigned early-stage programs.
Risk Management & Compliance
- Identify regulatory risks on assigned programs and recommend mitigation plans to the VP, Global Regulatory Strategy.
- Monitor evolving global health authority regulations and guidelines, maintaining submission compliance for assigned assets.
- Manage responses to health authority queries, variations, and post-approval requirements for assigned early-stage programs.
Position Requirements
Education and Experience:
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (advanced degree preferred).
- 8+ years of experience in Regulatory Affairs, with strong early-stage (IND/CTA) submission experience.
- Strong experience in clinical regulatory submissions (CTAs, INDs) and early-stage development. Working knowledge of global regulatory frameworks (FDA, EMA, TGA, PMDA, Health Canada, Medsafe).
- Experience preparing for and supporting health authority interactions. Strong knowledge of ICH guidelines, CTD/eCTD submissions, and the regulatory lifecycle
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
At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development.
Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs or related field; 8+ years Regulatory Affairs experience with early-stage IND/CTA submissions; knowledge of global regulatory frameworks and ICH guidelines.
Key Responsibilities
- developing regulatory strategy
- preparing submissions
- interacting with health authorities
Job Details
- Category: Healthcare Services - Advanced Practice
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — Canada or United States
- Languages: English
Benefits
- Generous paid time off
About Telix Pharmaceuticals (AMER)
A radiopharmaceutical company delivering precision medicine through targeted radiation. — Industry: Healthcare