Jackline Mokaya serves as the Associate Director of Global Regulatory Affairs (GRA) CMC at Takeda, where she leverages over 14 years of extensive experience in Global CMC Pharmaceutical Regulatory Affairs. In her current role, Jackline is responsible for providing strategic leadership for the regulatory CMC...
Jackline Mokaya serves as the Associate Director of Global Regulatory Affairs (GRA) CMC at Takeda, where she leverages over 14 years of extensive experience in Global CMC Pharmaceutical Regulatory Affairs. In her current role, Jackline is responsible for providing strategic leadership for the regulatory CMC development, registration, and post-approval strategies of small molecules marketed products. Her expertise encompasses a comprehensive understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and regulatory compliance, ensuring that Takeda's products meet stringent global standards.
Jackline has successfully managed and overseen the operations of the Regulatory Affairs and Compliance Department, demonstrating her ability to navigate complex regulatory landscapes. Her extensive experience includes managing global regulatory submissions, particularly within European Procedures such as the Mutual Recognition Procedure (MRP), Centralized Procedure (CP), and Decentralized Procedure (DCP) for marketing applications. This expertise is critical in facilitating timely product approvals and maintaining compliance with evolving regulatory requirements.
In addition to her regulatory acumen, Jackline is adept in change control processes, validation, and the intricacies of 21 CFR Part 11, which governs electronic records and signatures in the pharmaceutical industry. Her commitment to excellence and her strategic approach to regulatory affairs not only enhance Takeda's operational efficiency but also contribute to the overall success of the organization in delivering innovative therapies to patients worldwide. Jackline’s leadership in regulatory CMC is pivotal in navigating the complexities of the pharmaceutical landscape, ensuring that Takeda remains at the forefront of compliance and innovation.
