Manager, Global Regulatory Affairs

Summary

Join Telix Pharmaceuticals as the Manager, GRA, Global, overseeing Regulatory Affairs for the global commercial registration of the PSMA portfolio. This role involves managing regulatory tasks for new product development, securing registrations, and managing the product lifecycle. You will provide comprehensive support for clinical and commercial registrations worldwide, assisting the Associate Director, GRA Global. Key responsibilities include developing and implementing regulatory strategies, managing submissions, communicating with regulatory authorities, and collaborating with cross-functional teams. The position requires a Bachelor's degree in science, 7+ years of experience in Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment, and extensive experience with the FDA. Telix offers competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days, and support for learning and development.

Requirements

• Bachelor’s degree (science) required
• 7+ years’ experience leading Regulatory Affairs in the Nuclear Medicine or Pharmaceutical environment required
• Extensive experience in collaborating with the FDA required
• Experience working in a USFDA-regulated environment
• Demonstrated knowledge of Regulatory and ICH guidelines
• Strong communication skills, effective across all levels of the organization

Responsibilities

• 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
• 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
• 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

Preferred Qualifications

• 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

Benefits

• Competitive salaries
• Annual performance-based bonuses
• An equity-based incentive program
• Generous vacation
• Paid wellness days
• Support for learning and development