Associate Director, Global Regulatory Affairs
- Employer
- Takeda
- Location
- Boston, Massachusetts
- Start date
- Oct 22, 2024
View more categoriesView less categories
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Genetown, Best Places to Work
Job Details
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Job DescriptionTakeda 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.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeCompany
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation. Today, our organization spans the globe—colleagues across business units and functions face challenges head-on to deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.
As a values-based, R&D-driven biopharmaceutical leader headquartered in Japan, we focus our R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. In addition to our R&D efforts, we’re laser-focused on harnessing the power of data, digital, and technology to improve health outcomes for patients across the globe.
Since our founding in Japan, integrity and putting patients first have been at the heart of our identity. We're proud of our employees and their commitment to improving the quality of life for patients, and to working with our partners in health care in approximately 80 countries and regions. With each new breakthrough comes opportunities to develop your career, hone new skills, and create a brighter future
For more information, visit https://jobs.takeda.com/
- Website
- https://www.takeda.com/
- Location
-
650 East Kendall Street
Cambridge
MA
02421
United States
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