Belinda Davis

Senior Manager, Gra, Apac @Telix Pharmaceuticals Limited

Melbourne, AU

Oversee Regulatory Affairs for commercial registration activities across the Asia-Pacific region, conducting regulatory tasks related to new product development, securing registrations, and managing the product lifecycle within the APAC markets.Provide comprehensive support for clinical and commercial registrations across the APAC region, while also assisting in Precision Medicine global projects.Key Accountabilities:• Regulatory Strategy and Planning - Develop and implement regulatory strategies for clinical, commercial, and lifecycle management of products in the region APAC. Plan submissions for INDs, NDAs, MAAs, or other relevant regulatory filings in collaboration with cross-functional teams.• Compilation of IND/NDA dossiers for Telix assets in the APAC region.• Develop 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.• Communication with Regulatory Authorities - Efficient communication with the applicants, strategies preparation and presentation for institutions (e.g.TGA Australia, CDE China, PMDA-Japan and other local health authorities from the region).• 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• 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.

Deakin University

BSc(Hons)(H1), Renal Physiology

University of Melbourne

PhD, Diabetic Kidney Disease

Deakin University

BSc(Biol Sci), Microbial Genetics