Michelle Gafa Featured Image

Michelle Gafa

Senior Director, Regulatory Affairs

Michelle is an expert in the regulatory aspects of chemistry, manufacturing and controls (CMC) and abridged applications. She has worked in regulatory affairs for 27 years.

Michelle holds a bachelor’s degree in pharmacy from the University of Malta, a master’s degree in business administration from Henley Management College.
Before moving into consultancy in 2014 after 18 years in industry, she managed a team of CMC regulatory specialists at Actavis, participating in and leading development project teams and advising manufacturing sites on the regulatory impact of technical transfers and other complex changes.

Michelle is in charge of tranScrip’s Malta office. Her team provides CMC, regulatory intelligence and strategic support to companies with clinical-stage and established products. She coordinates cross-functional teams delivering marketing authorisation and major variation applications and has extensive experience with multiple dosage forms.

Michelle is a member of TOPRA.

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