Michelle Gafa

Michelle is an Executive Director, Regulatory Affairs at tranScrip where she leads a team of experienced regulatory affairs professionals. She has worked in regulatory affairs for 28 years – in industry for 18 years and consultancy for 10 years. Her main areas of expertise are the regulatory aspects of chemistry, manufacturing and controls (CMC), as well as regulatory strategy, procedure management and intelligence.

Michelle moved from pharmaceutical manufacturing (Pharmamed / Delta / Actavis) to consultancy in 2014, first as a freelancer, then joined Real Regulatory as managing consultant in 2015 and eventually tranScrip upon the acquisition of Real Regulatory in 2022.

At tranScrip, she is responsible for the development and execution of regulatory strategies in support of clients’ corporate objectives. She provides CMC expertise, regulatory intelligence, strategic advice and due diligence to a wide variety of clients and has managed many regulatory procedures. Her involvement extends from preparation of regulatory roadmaps to scientific advice, from IMPD compilation for first-in-human studies to marketing authorisation applications and post-authorisation regulatory lifecycle management. She has worked with multiple dosage forms, small molecules, biologicals and ATMPs. Throughout her career, Michelle has been involved in change control evaluation and technical transfers, advising QPs on the regulatory impact of complex CMC changes.

Michelle trained as a pharmacist at the University of Malta and holds an MBA from Henley Management College.

She is a registered member of TOPRA.