Etienne Marchot, Ph.D. Email & Phone Number

In fast-paced innovative environments I watch for regulatory compliance and contribute to successful product development and overall regulatory and business strategiesMy professional profile is initially built on scientific credentials (Ph.D.) in combination with international management. Recently I add new expertise in Regulatory Affairs that I studied at University of Liège. I first apply this new knowledge to Solvay Specialties to contribute to prospective excipients used in drug device combinations. Then I join GSK internal consulting team devoted to marketing authorisation applications of drugs. Our mission : to align autorisation process to formal requirements, to create regulatory documentation that supports GSK internal users.In fact, my main areas of contribution are :• Analyzing published & upcoming regulations on new substances (EMA, Eudralex, FDA, ICH,...)• Planning, documenting and structuring marketing authorization requirements for new products (eCTD, variations,...)• Exploring risk issues with new substances market release (RMP, Pharmacovigilance, REACH,...)• Consolidating regulatory, technical & competitive intelligence sources toward an integrated analysis• Networking with regulatory agencies & authorities (EMA, EDQM, CDER, National Agencies)I am keen to join organizations of any size as a Regulatory Affairs team member. Such regulatory role can be combined with a quality or management function, as found in SME’s, project-driven bodies, networks or partnerships, larger structures that value initiatives and proactivity.In addition to regulatory responsibilities, I am keen to :• Promote continuous improvements through established quality tools (process approach, TQM, ISO standard,...)• Develop internal and external communication through written and informal channels• Contribute to innovation through effective methods, workshops and tools• Join projects whose success also depends on people skills and team spiritOther Keywords : Pharmaceuticals, Chemistry, Biotechnology, Food and Feed, Agrochemicals, Nutraceuticals, Cosmetics, Project Management Body of Knowledge (PMBOK), EFQM

Listed skills include Change Management, Strategy, Business Strategy, Management, and 21 others.