Takeda Pharmaceuticals
Associate Director, Global Regulatory Affairs
Takeda Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
Takeda 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: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
https://jobs.takeda.com
and search for Req # R0136180.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
#J-18808-Ljbffr
Takeda 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: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
https://jobs.takeda.com
and search for Req # R0136180.Locations
Boston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time
#J-18808-Ljbffr