Principal Consultant at PAREXEL

Michael Craig

 Michael Craig

As a Principal Consultant at PAREXEL, Michael Craig helps clients prepare their CTA, marketing authorisation and variation submissions as a CMC Subject Matter Expert and provides regulatory and technical input for lifecycle activities in European and international markets.

Before joining PAREXEL in 2015, Michael Craig worked for more than 5 years as a Pharmaceutical Assessor at the Medicines and Healthcare products Regulatory Agency (MHRA). Regulatory expertise includes the assessment of initial applications under a variety of legal basis as well as variations to existing licences.

Assessment work performed for MHRA entailed national and EU applications which covered DCPs, MRPs, centralised (Rapp and Rapp peer reviewer) and the assessment of NCEs.

Helped to 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 ITF.

He is author or co-author of the following chapter of GMP Compliance Adviser:

  • 0.B Cannabis