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The CMC Regulatory Affairs Manager at Katalyst Healthcares & Life Sciences is a pivotal role that involves overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of regulatory submissions in the pharmaceutical industry. This position requires a deep understanding of regulatory requirements and guidelines, particularly those related to CMC for pharmaceutical products. The successful candidate will be responsible for preparing CMC sections of various regulatory submissions, including Investigational New Drug applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and Investigational Medicinal Product Dossiers (IMPDs). Interaction with global health authorities such as the FDA, EMA, Health Canada, and PMDA is a critical component of this role, necessitating strong communication and collaboration skills. In addition to regulatory submissions, the CMC Regulatory Affairs Manager will be expected to stay abreast of global regulatory requirements and guidelines, including ICH guidelines and EudraLex. The role demands excellent project management skills, as the manager will need to prioritize tasks and manage multiple projects simultaneously while ensuring compliance with all regulatory standards. A detail-oriented mindset is essential, with a focus on quality and accuracy in all submissions. The ideal candidate will have a proven track record in regulatory affairs CMC, with experience in small molecules, biologics, or other pharmaceutical modalities being highly desirable. Regulatory Affairs Certification (RAC) is considered a plus, further enhancing the candidate's qualifications for this senior-level position.
