Job 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
To support the Group’s strategic objectives, the Manager, GRA, Global will oversee Regulatory Affairs for commercial registration activities of PSMA portfolio globally. This role involves conducting regulatory tasks related to new product development, securing registrations, and managing the product lifecycle globally.
This role will provide comprehensive support for clinical and commercial registrations across global, while also assisting the Associate Director, GRA Global.
Key Accountabilities:
- Regulatory Strategy and Planning - Develop and implement regulatory strategies for clinical, commercial, and lifecycle management of products globally. Plan submissions for INDs, NDAs, MAAs, or other relevant regulatory filings in collaboration with cross-functional teams.
- Support the compilation of IND/NDA dossiers for Telix assets globally by collaborating closely with individual product regulatory leaders.
- Assist in developing registration strategies and managing the registration process through collaboration with cross-functional teams.
- Submission Management - Review and approve regulatory submissions to ensure quality, accuracy, and compliance with local and global requirements. Monitor submission timelines and ensure timely responses to regulatory authority queries.
- Stay up to date on changes in regulatory guidelines and advise internal teams on their impact.
- Provide assistance to the product regulatory leaders by reviewing change controls, as well as quality and manufacturing data for global projects and multi-regional clinical trials.
- Communication with Regulatory Authorities - Efficient communication with the applicants, strategies preparation and presentation for institutions (with the USFDA).
- Interfacing internally with QA, Clinical Development, Research and Innovation and other functions involved to ensure that dossiers are presented within the scheduled deadlines and that the material provided meets regulatory requirements.
- Participate in decision-making processes to align regulatory priorities with business objectives.
- Provide expert advice to senior management on regulatory risks and opportunities.
- Collaborate closely with regional teams, including Commercial, Supply Chain, Quality, and Strategic teams, to manage ongoing business commitments while ensuring compliance with the latest regulatory requirements.
Education and Experience:
- Bachelor’s degree (science) minimum
- 7+ years’ experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment required
- Extensive experience in collaborating with the FDA.
- Experience working in a USFDA-regulated environment
- Demonstrated knowledge of Regulatory and ICH guidelines.
Key Capabilities:
- Strong communication skills, effective across all levels of the organization.
- Extensive experience in Regulatory Affairs, particularly with the TGA in Australia, and ideally, experience working with regulatory authorities across the Asia-Pacific region.
- Proficient understanding of both early and late-stage drug development processes, including clinical and non-clinical requirements, at an advanced level.
- Strong ability to collaborate effectively with teams across the region.
- Demonstrate a dedication to continuous learning and professional growth, actively pursuing opportunities to enhance your expertise and skill set.
- Uphold integrity and exhibit a steadfast commitment to ethical conduct in all dealings with colleagues and stakeholders.
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.
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