Mic McGoldrick serves as the Associate Director of CMC Policy at Merck, where he plays a pivotal role in shaping global regulatory frameworks related to Chemistry, Manufacturing, and Controls (CMC) and Quality issues. With a strong focus on vaccines and biologics, Mic is dedicated to...
Mic McGoldrick serves as the Associate Director of CMC Policy at Merck, where he plays a pivotal role in shaping global regulatory frameworks related to Chemistry, Manufacturing, and Controls (CMC) and Quality issues. With a strong focus on vaccines and biologics, Mic is dedicated to advocating for streamlined regulatory processes that enhance patient access to life-saving therapies. His work with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and BioPhorum underscores his commitment to fostering collaboration among industry stakeholders to achieve regulatory convergence.
In his current role, Mic is actively involved in addressing both draft and final guidance documents issued by regulatory agencies, ensuring that CMC issues are effectively represented and understood. His expertise in regulatory submissions, aseptic processing, and Good Manufacturing Practices (GMP) enables him to provide strategic insights that influence policy decisions and drive innovation within the pharmaceutical industry. By focusing on the reduction of redundant regulatory requirements for clinical trials, CMC, and lot release, Mic aims to accelerate the approval process for vaccines and biologics, ultimately improving patient outcomes.
Mic’s strategic planning skills are complemented by his extensive knowledge of the electronic Common Technical Document (eCTD) format, which is essential for efficient regulatory submissions. His commitment to advancing CMC policy not only enhances Merck's operational efficiency but also contributes to the broader goal of increasing global access to critical healthcare solutions. Through his leadership and advocacy, Mic McGoldrick is making significant strides in the regulatory landscape, ensuring that patients receive timely access to innovative therapies.
