As Senior Director, Regulatory Science, Mark is responsible for assisting clients to define the regulatory strategies for the global development and registration of drugs, biologics & cell and gene therapy products, especially those for life-threatening diseases.
Mark has a proven history of building and maintaining good relationships with FDA personnel to facilitate the development and commercialization of new products (Orphan Products, PDUFA meetings, CBER, and CDER Review Divisions including OTAT). He has managed post-approval submissions of all types, including advertising and promotional materials, drug product listings, CMC, and labeling supplements.
He has also worked on several types of EMA mechanisms and submission types, including ODD, MAA, Scientific Advice, Pediatric.
Mark has been engaged in regulatory affairs for more than 20 years and has experience with the preparation and submission of applications such as CTA, IMPD, INDs, NDAs, BLAs, MAAs, ODDs, and post-approval submissions of all types. Mark’s professional industry experience encompasses the oncology area, hemostasis, AIDS, neuropharmacological disorders, colony-stimulating factor, and ophthalmology therapeutic areas. He has worked predominantly with recombinant proteins, small molecules, and cellular therapy products in all phases of development (pre IND – Phase 3).
Mark served as the regulatory team leader and was responsible for coordination, preparation, review, publication, submission, and approval of several new NDAs and BLAs, as well as numerous INDs.
Mark has a Bachelor of Science degree in Biology with a minor in Chemistry from Northeastern Illinois University in Chicago, IL.
Mark is based in the Seattle, Washington area and regularly commutes to VCLS offices in Cambridge, MA.
Resources by Mark Gauthier
webinar
Achieve Success for Your US Product Application
The introduction of a new medicinal product to the US market follows a complex process that may extend many years…
publication
Expedited access of cellular and gene therapy products: The EU versus the US
There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT)…
