Takeda Pharmaceutical
Associate Director, Global Regulatory Affairs
Takeda Pharmaceutical, Boston, Massachusetts, us, 02298
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest that all information I submit in my employment application
is
true to the best of my knowledge.
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
https://jobs.takeda.com
and search for Req # R0136180. Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time By applying, you consent to your information being transmitted by Disability Solutions to the Employer, as data controller, through the Employer’s data processor SonicJobs. See Takeda Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/ and Privacy Policy at https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions
the information I provide in my application will be processed in line with
Takeda’s
Privacy Notice
and
Terms of Use .
I further attest that all information I submit in my employment application
is
true to the best of my knowledge.
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
https://jobs.takeda.com
and search for Req # R0136180. Locations
Boston, MA
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time By applying, you consent to your information being transmitted by Disability Solutions to the Employer, as data controller, through the Employer’s data processor SonicJobs. See Takeda Pharmaceutical Terms of Use at https://www.takeda.com/terms-of-use/ and Privacy Policy at https://www.takeda.com/privacy-notice/ and SonicJobs Privacy Policy at https://www.sonicjobs.com/us/privacy-policy and Terms of Use at https://www.sonicjobs.com/us/terms-conditions