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I am an accomplished regulatory and project management professional with over 30 years of pharmaceutical development, working for small and large biotech/pharma organizations, Biomarin, Takeda, Millennium, Chugai, Roche, and Syntex. I am experienced in handling orphan and non-orphan projects (small molecules, biologics, ATMPs) in all therapeutic areas from initial conception through to post MA life cycle management. I have built, developed and retained teams of regulatory professionals both locally and globally and have also led internal multidisciplinary project teams. I have an in depth knowledge of and experience in global regulatory affairs, regulatory research & intelligence and policy and have a strong background in delivering & executing on Global Regulatory Strategies and Clinical Development Plans. I also have extensive experience in working closely with Business Development colleagues in both corporate and product acquisitions.
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