Daisy Hopper is a dedicated Regulatory Affairs Consultant at Amgen, where she leverages her robust background in forensic science from the University of Lincoln to navigate the complex landscape of regulatory compliance in the biotechnology sector. With a focus on Oncology, Immunology Brands, and Biosimilars,...
Daisy Hopper is a dedicated Regulatory Affairs Consultant at Amgen, where she leverages her robust background in forensic science from the University of Lincoln to navigate the complex landscape of regulatory compliance in the biotechnology sector. With a focus on Oncology, Immunology Brands, and Biosimilars, Daisy plays a pivotal role in ensuring that Amgen’s innovative therapies meet stringent regulatory standards across Ireland and the United Kingdom. Her expertise in regulatory operations is complemented by her proficiency in the Clinical Trials Information System (CTIS) and her deep understanding of post-approval processes, which are critical for maintaining compliance throughout the product lifecycle.
Daisy’s current projects involve strategic planning for Marketing Authorization Applications (MAA) submissions, where her keen insight into European guidelines and Good Clinical Practice (GCP) ensures that all submissions are not only timely but also of the highest quality. Her problem-solving skills are instrumental in addressing regulatory challenges, enabling her to devise effective strategies that align with both corporate objectives and regulatory requirements. Furthermore, her exceptional interpersonal skills foster strong relationships with cross-functional teams, regulatory authorities, and stakeholders, facilitating seamless communication and collaboration.
In a rapidly evolving industry, Daisy remains committed to continuous learning and adaptation, staying abreast of the latest regulatory developments and trends. Her passion for life sciences and dedication to regulatory excellence position her as a valuable asset to Amgen and the broader healthcare community, where she contributes to the advancement of safe and effective therapies for patients in need.
