Associate Director, Global Regulatory Affairs

Job DescriptionTakeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA. The candidate must have a Master's degree in Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field, along with 7 years of related experience. Prior experience must include:All candidates should make sure to read the following job description and information carefully before applying.Serving as the Global and US Regulatory Strategic Lead (GRL) on the global project team (GPT) for accountable individual projects in the immunology and inflammation therapeutic franchise.Providing global regulatory oversight and executing regulatory activities on late-stage development in multiple indications, device platforms, and cell line changes.Global experience of health authority interactions, including preparation for meetings with FDA (type B, end of phase 2 meeting), EMA (EU central scientific advice), BRDD (Canada Scientific Advice), and PMDA (Japan Scientific Advice).Leading the development of high-level global regulatory supplemental biologic application (sBLA) strategy and the KO of the global cross-functional submission working group.Leading global submission strategy across multiple respiratory indications and collaborating with the global regulatory team to ensure multiple global pre-submission meetings and marketing application submissions.Up to 20% domestic and international travel required.Full time position with a salary range of $212,400.00 - $290,400.00/year.Apply online at search for Req # R0136180.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#J-18808-Ljbffr

Created: 2024-11-12