Ciby Abraham is a seasoned Senior Director and Group Manager in Project and Product Leadership within CMC Regulatory Affairs at AstraZeneca, where he plays a pivotal role in shaping the regulatory landscape for a diverse portfolio of pharmaceutical products. With extensive experience in the pharmaceutical...
Ciby Abraham is a seasoned Senior Director and Group Manager in Project and Product Leadership within CMC Regulatory Affairs at AstraZeneca, where he plays a pivotal role in shaping the regulatory landscape for a diverse portfolio of pharmaceutical products. With extensive experience in the pharmaceutical industry and a strong background in FDA regulations, Ciby leads a global regulatory CMC team that is dedicated to delivering comprehensive end-to-end regulatory strategies for drug development projects spanning from Phase 1 through to the end of their lifecycle. His expertise encompasses a wide range of therapeutic areas, including oncology, respiratory, immunology, cardiovascular, renal, and metabolism, allowing him to navigate the complexities of drug development across various stages and therapeutic indications.
Ciby’s leadership is instrumental in driving key projects that require a deep understanding of CMC regulatory requirements, ensuring compliance while optimizing the development process. His proficiency in analytical techniques such as HPLC, LC-MS, and NMR, combined with his knowledge of quality assurance and pharmaceutical process development, enables him to effectively oversee the intricacies of drug formulation and manufacturing. Ciby is also adept at implementing CAPA (Corrective and Preventive Actions) and scale-up strategies, ensuring that products not only meet regulatory standards but also maintain high quality throughout their lifecycle.
In his current role, Ciby is committed to fostering collaboration across multidisciplinary teams, leveraging his insights to align regulatory strategies with business objectives. His ability to anticipate regulatory challenges and devise proactive solutions has made him a key asset in advancing AstraZeneca's mission to deliver innovative therapies that improve patient outcomes globally.
