Regulatory Affairs, Marketed Products POSITION DESCRIPTION: Takeda Development Center Americas, Inc. is seeking a Manager..., Global Regulatory Affairs, Marketed Products with the following duties: Assist the Global Regulatory Lead (GRL...
Job Description Summary The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible... Novartis innovative medicines portfolio, including its marketed products. The RDM works with oversight of senior members of the...
execution of multi-product global regulatory CMC strategies for investigational and marketed products. This role leads the... strategies for investigational and/or commercial products Collaborates with regulatory colleagues in development of global...
of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable... topics. This role provides regulatory guidance to various cross-functional teams to ensure all applicable global regulatory...
development of global labeling (CCDS, USPI, EU SmPC and other markets as necessary) on one or more marketed products. This role... requirements globally, including development and life-cycle management of CCDS and of global regulatory authorities, including the...
and maintenance of global product labeling for marketed products, as well as pipeline activities for the cystic fibrosis (CF... regarding labeling requirements globally, including development and life-cycle management of TLPs, CCDS and of global regulatory...
, marketed or in development. The Patient Safety ARRM Manager will collaborate closely with Global Patient Safety Physicians... for Vertex products, marketed or in any phase of development Prepares aggregate safety reports, including establishment...
functions for marketed products and drugs in development. Maintain up-to-date working knowledge and adherence..., US Medical Immunology team, as a valued strategic partner with Clinical, Commercial, Regulatory and Market Access to bring...