Brian J. Malkin

Brian J. Malkin

Associate General Counsel, Teva Pharmaceuticals

Bio:
Brian J. Malkin supports Research and Development (R&D), Regulatory Affairs (RA), Commercial, Quality, Quality Assurance, and other client groups by counseling on FDA regulatory law and strategy, including expedited development pathways, labeling and safety issues, and pre-and post-approval development challenges. He serves as a Center of Excellence in regulatory law, including the issues under the FDCA, PHSA, BPCIA, PREA, BPCA, the Hatch-Waxman Act, the Orphan Drug Act, the User Fee Act and other laws. He represents Teva in informal and formal dispute resolution and litigation and develop advocacy strategies, submissions, appeals, and correspondence. He sits on R&D project teams across therapeutic areas to advise on legal and regulatory issues and post-approval development for innovative and biosimilar pharmaceutical products. He developes and maintains relationships with health authorities, external facing organizations, trade associations, and pharmaceutical industry counterparts. He also provides training for RA, R&D, and commercial functions on FDA legal and regulatory issues.