Senior Manager, Global Regulatory Strategy

Telix Pharmaceuticals (AMER)

4d•Hybrid

About The Position

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.

Requirements

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.
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

Responsibilities

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.
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.
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.
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.