Craig Donnelly

Craig Donnelly has extensive work experience in the pharmaceutical industry, starting with their role as an Industrial Trainee in the Analytical Sciences Department at Sanofi in 1997. Craig then joined Pfizer in 1999, where they held positions ranging from Senior Scientist to Principal Scientist, focusing on Analytical R&D for late-stage drug products. Craig played a key role in the development and filing of various drug products and authored analytical sections for regulatory submissions.

In 2011, Donnelly joined the Almac Group as an Analytical Team Leader, where they managed a group of analytical chemists and successfully led a MHRA inspection of the Elvingston analytical laboratory, resulting in the granting of GMP licenses. Craig then joined Roche in 2013 as a Senior Regulatory Consultant, providing technical and strategic guidance for global regulatory filings and implementing QbD approaches to development.

Donnelly's regulatory expertise led him to roles at Mapi Group and Mapi Group: Health Research & Commercialization, where they served as Director, Head of Global Regulatory Affairs, CMC, and as Director Regulatory Affairs CMC and Regulatory Affairs Europe and International. Craig specialized in regulatory CMC and analytical consulting.

From 2014 to 2017, Donnelly founded and directed Craigdhu Consulting Ltd, offering management consultancy services, including regulatory CMC and analytical consultancy.

Most recently, Donnelly held positions at NuCana plc and Achieve Life Sciences, serving as Vice President, CMC and Regulatory CMC for NuCana plc before being promoted to Senior Vice President, CMC and Regulatory CMC at Achieve Life Sciences.

Throughout their career, Donnelly has exhibited strong leadership, expertise in regulatory affairs, and a track record of successful regulatory filings and inspections.

Craig Donnelly attended South Tyneside College from 1993 to 1995. However, no degree or field of study is available for this period. From 1995 to 1999, Craig Donnelly pursued a degree in Chemical and Pharmaceutical Sciences at the University of Sunderland, focusing on chemistry and pharmaceutical science.