Sr. Manager, Global Regulatory Strategy at Telix Pharmaceuticals (Americas)

, , United States -

Full Time

Start Date

Immediate

Expiry Date

09 Sep, 26

Salary

0.0

Posted On

11 Jun, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Strategy, Global Regulatory Frameworks, Health Authority Engagement, Oncology, Radiopharmaceuticals, Project Management, Cross-functional Collaboration, Lifecycle Management, Risk Management, Dossier Preparation, Clinical Development, CMC, Market Access, Regulatory Planning, Communication Skills, Strategic Planning

Industry

Pharmaceutical Manufacturing

Description

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 Sr. Manager, Global Regulatory Strategy supports the Group’s strategic objectives by contributing to the development and execution of regulatory strategies for global development and commercialization programs. This role partners with senior regulatory leadership to support regulatory planning across assigned programs, including development, registration, and lifecycle activities. The Senior Manager is responsible for supporting global regulatory strategy execution across pipeline and/or marketed programs, ensuring alignment between regulatory activities and broader development and commercial objectives. This includes contributing to the evaluation of regulatory pathways, assisting in the preparation for health authority interactions, and supporting efforts to optimize timelines, risk management, and market access outcomes. This role collaborates cross-functionally to support regulatory planning and execution, provides input on regulatory risks and considerations, and helps ensure consistent and timely delivery of regulatory milestones across assigned programs. Key Accountabilities: Regulatory Strategy and Planning Support the development and execution of regulatory strategies for assigned portfolio assets, ensuring alignment with program objectives and global regulatory requirements Contribute to regulatory planning for new product development, global submissions, and lifecycle management activities across pipeline and commercial assets. Partner cross-functional to help align regulatory strategies with clinical, CMC, and commercial plans. Maintain awareness of global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) and apply them to program-level strategy and execution. Identify regulatory risks and support development of mitigation plans in collaboration with senior regulatory leadership. Health Authority Engagement & Submissions Lead the preparation for Health Authority interactions and submissions, including preparation of briefing documents, dossiers and other documentation in alignment with regulatory requirements. Manage responses to Health Authority queries and support regulatory milestone deliverables. Ensure documentation and communications are complete, accurate, and aligned with agreed regulatory strategies. Cross-Functional Leadership & Influence Serve as the regulatory lead on assigned R&D project teams and partner cross-functionally with Clinical, Quality, CMC, Commercial, non-clinical and regulatory functions to support integration of regulatory considerations into development and commercialization plans. Participate in cross-functional teams to ensure alignment and timely execution of regulatory activities. Provide input and recommendations on regulatory risks, opportunities, and implications across the global portfolio. Coordinate with regional stakeholders to support execution of global regulatory strategies at the regional level. Education and Experience: Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Regulatory Affairs, or related scientific field required. Advanced degree (MS, PhD, PharmD) preferred. 8+ years of experience within pharmaceuticals, biotech, or life sciences 5+ years of experience in Regulatory Affairs Strong background in regulatory strategy for oncology or radiopharmaceutical products is highly desirable. Proven experience with global regulatory frameworks (e.g., FDA, EMA, TGA, PMDA, CDE) Prior experience contributing to health authority interactions (briefing support, responses, documentation) Experience working on cross-functional teams (Clinical, CMC, Quality, etc.) Solid understanding of drug development process and regulatory requirements across development and commercialization Ability to translate regulatory guidance into program-level actions Strong project management and organizational skills; able to manage multiple priorities Effective cross-functional collaboration and communication skills Ability to identify risks and escalate appropriately, with sound judgment 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 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. VIEW OUR PRIVACY POLICY HERE

Responsibilities

Develop and execute global regulatory strategies for the development and commercialization of oncology and rare disease products. Lead health authority interactions and collaborate cross-functionally to ensure timely delivery of regulatory milestones.