What are the responsibilities and job description for the Associate Director, Global Regulatory Affairs position at Takeda pharmaceutical?
Job Details
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Job Description
Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with the following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, cell line changes; Global experience of health authority interactions including preparation meetings with FDA, US (type B, end of phase 2 meeting), EMA, (EU) central scientific advice, BRDD, (Canada) Scientific Advice and PMDA, (Japan) Scientific Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy and the KO of global cross functional submission working group. Lead global submission strategy across multiple respiratory indications and worked with global regulatory team to ensure multiple global pre-submission meetings and marketing application submissions. Up to 20% domestic and international travel required.
Full time. $212,400.00 - $290,400.00 /year.
Apply on-line at and search for Req # R0136180.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Description
Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs in Cambridge, MA with the following requirements: Master's degree in Pharmacy, Biomedical Engineering, Regulatory affairs or related field plus 7 years of related experience. Prior experience must include: In the immunology and inflammation therapeutic franchise, serve as the Global and US Regulatory Strategic Lead (GRL), on the global project team (GPT) for accountable individual projects; Provide global regulatory oversight and execute regulatory activities on late-stage development in multiple indications, device platforms, cell line changes; Global experience of health authority interactions including preparation meetings with FDA, US (type B, end of phase 2 meeting), EMA, (EU) central scientific advice, BRDD, (Canada) Scientific Advice and PMDA, (Japan) Scientific Advice; Lead the development of high level global regulatory supplemental biologic application sBLA strategy and the KO of global cross functional submission working group. Lead global submission strategy across multiple respiratory indications and worked with global regulatory team to ensure multiple global pre-submission meetings and marketing application submissions. Up to 20% domestic and international travel required.
Full time. $212,400.00 - $290,400.00 /year.
Apply on-line at and search for Req # R0136180.
Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Salary : $212,400 - $290,400
