Michael Craig

With expertise in chemicals, manufacturing, and controls (CMC) and regulatory affairs, Michael focuses on guiding companies in the best regulatory and CMC approach. He has strong experience in preparing CMC drug development strategies, regulatory dossier and advising on regulatory authorities’ interactions for global markets in a variety of therapeutic areas and dosage forms.

Work experience

A registered pharmacist, with more than 15 years of regulatory experience that includes 6 years of working as a Pharmaceutical Assessor at the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Michael’s assessment work for MHRA entailed national and EU applications, which covered decentralized procedures, mutual recognition procedures, and new chemical entities.

When in the Agency, he was also part of the team that helped establish the MHRA Innovation Office as an entry point for early-stage regulatory advice for innovative products and methodologies and was the UK representative for the growing EU Innovation Network chaired by the EMA Innovation Task Force. 

Michael is a current member on the planning committee for the Regulatory Affairs Professional Society (RAPS) Euro Convergence conference and has contributed to the RAPS as an author of several publications and presenter at numerous conferences.

In his current position with Parexel, he provides regulatory, strategic, and technical CMC input throughout the products lifecycle, support Heath Authorities interactions and helps clients prepare their global applications both for investigational and new drugs. 

Education

He has a pharmacy degree from Trinity College, Dublin and is a registered pharmacist in Ireland.