Michelle Gafa Featured Image

Michelle Gafa

Executive 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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We invite you to explore exciting opportunities with us and become a part of a dynamic team dedicated to excellence. Share your expertise and embark on a rewarding journey with tranScrip.

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Our experienced physicians and scientists, together with our regulatory, clinical and commercial experts can support you to maximise the value of your products. Whatever your project requires, we have the expertise to meet your needs.