Walter Holberg is a seasoned Regulatory Submissions Project Manager at Pfizer, where he plays a pivotal role in ensuring the successful navigation of regulatory landscapes for new drug applications (NDAs) across multiple countries. With a strong foundation in Chemistry, Manufacturing, and Controls (CMC), Walter brings...
Walter Holberg is a seasoned Regulatory Submissions Project Manager at Pfizer, where he plays a pivotal role in ensuring the successful navigation of regulatory landscapes for new drug applications (NDAs) across multiple countries. With a strong foundation in Chemistry, Manufacturing, and Controls (CMC), Walter brings extensive expertise in overseeing regulatory compliance and quality assurance processes for both small molecule drugs and drug-device combination products. His current responsibilities involve program management of cross-functional project teams, where he effectively coordinates the authoring, review, and approval of critical regulatory submission documents.
Walter's collaborative management style fosters an environment of innovation and out-of-the-box thinking, empowering his teams to tackle complex challenges in drug development. He leverages his deep knowledge of regulatory affairs and analytical techniques, including high-performance liquid chromatography (HPLC) and validation processes, to ensure that all submissions meet stringent regulatory standards set forth by the U.S. Food and Drug Administration (FDA) and other global regulatory bodies. His commitment to excellence in regulatory compliance not only enhances the quality of submissions but also accelerates the time-to-market for life-saving therapies.
Key projects under Walter's leadership have included the successful launch of several high-profile NDAs, where his strategic oversight and meticulous attention to detail have been instrumental in achieving regulatory milestones. His ability to engage with stakeholders and provide exceptional customer service further solidifies his reputation as a trusted leader in the field. As the pharmaceutical landscape continues to evolve, Walter remains dedicated to advancing regulatory practices that support innovation and improve patient outcomes.
