Regulatory Expert Mark Gautier

Senior Director, Regulatory Science, Drugs & Biologics

Mark has a proven history of building and maintaining good relationships with FDA personnel to facilitate 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 regulatoy affairs for more than 20 years and has experience with 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 (preIND – 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 regulary commutes to VCLS offices in Cambridge, MA.


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