Director & Legal Counsel - Us Innovative Medicines & Biosimilars Division
CurrentMichael serves as Director & Legal Counsel to Teva Pharmaceuticals, one of the world's largest multinational pharmaceutical companies. With a portfolio of more than 3,600 medicines and a commercial footprint in 27 international markets, Teva is able to provide a high-quality portfolio of specialty medicines, generics, biopharmaceuticals, and over-the-counter products to over 60 countries, serving approximately 200 million people every day.Through its Innovative Medicines & Biosimilars Division, Teva specializes in the development of proprietary pharmaceuticals & specialty treatments for disorders of the central nervous system (including neurological and neurodegenerative diseases, migraine, and movement disorders), and maintains a strong portfolio of treatments in the oncology and respiratory areas.To facilitate Teva’s goal of expanding its branded pipeline, Michael provides legal, regulatory, & compliance support to the innovative medicines division, specifically counseling Teva's portfolio of innovative treatments for schizophrenia, migraine, TD, and MS - which represent Teva's flagship and most-profitable portfolio of branded medicines. Michael ensures all relevant regulatory requirements are followed throughout the lifecycle of each product - from development, to promotion & marketing, and finally to sale. As such, Michael’s typical responsibilities include:(i) Managing the Promotional & Advertising Review Committee (PARC) and providing appropriate legal review of all marketing materials, external sales content, or internal sales trainings;(ii) Evaluating legislation that could affect Teva’s development or go-to-market strategies;(iii) Analyzing & approving any third-party relationship requests, including sponsorships, memberships, and patient/HCP engagements in compliance with the Anti-Kickback Statute; and (iv) handling any requests, audits, or inquiries received from the FDA, FTC, or other regulatory bodies.