Antonio Trejo

Vice President, Regulatory Affairs

Antonio Trejo has over 26 years of experience in drug development with expertise in providing regulatory, quality and compliance support to the Pharmaceutical, Biopharmaceutical, Consumer (Over-the-Counter and Cosmetics) and Medical Device industries.  He has supported New Product registrations (NDA, ANDA, BLA, IND, CTA, 510K, CTA, Investigational Medicine Product Dossier, Marketing Approval Application, Over-the-Counter, and Medical Device Pre Market Application), CMC and maintenance and the implementation of Quality Systems and preparation for inspection with the FDA and other major international agencies.

Antonio is recognized for Global Regulatory expertise in Specialty products – spanning Oncology, Rare disease, CNS, Pain, Women’s Health, Gastro Intestinal, Migraine, Cardio, Biologics, Gx, Biosimilars, OTC, Medical Devices and API products.  He has international experience with regulatory agencies in the US, Canada, Russia, Japan and Israel, in addition to countries across Latin America, Asia Pacific, Middle East and North Africa, and Europe.  He has held global oversight for all aspects of development, communication, implementation, maintenance and execution of the Regulatory and Compliance strategy.  Most recently Antonio was Head of Global Regulatory Compliance for Takeda pharmaceuticals.  A role in which he responsible for Takeda’s Compliance initiatives, and all regulatory systems, processes and innovation; enabling him to identify compliance vulnerabilities and risks related to regulatory affairs processes and to develop strategic initiatives and/or mitigation plans to reduce risk. He brings a rich set of experiences from a variety of multinational companies including Bayer, Wyeth, and Teva.

Antonio has a Bachelor’s in Pharmaceutical Chemistry, a Masters of Science in Pharmaceutical Technology, and an MBA.

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