Associate Director, Global Regulatory Affairs Strategy Lead
- Boston, Massachusetts
- Start date
- Mar 25, 2023
- Marketing, Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Genetown, Best Places to Work
Takeda Development Center Americas, Inc. is seeking an Associate Director, Global Regulatory Affairs Strategy Lead in Cambridge, MA with the following requirements: Bachelor’s degree in Biology, Chemistry, Pharmacy or related field or foreign academic equivalent. 8 years of related experience. Prior experience must include: Lead the Global Regulatory Team (GRT) and applicable sub-working groups and serve as direct point of contact with the FDA, accountable for US FDA submissions, addressing agency queries leading to approvals, and lead agency meetings including meeting preparation (4 yrs); lead REMS activities and submissions especially on REMS KAB surveys and Assessment Report submitted to the US FDA (3 yrs); perform regulatory submissions in eCTD format, per ICH and FDA guidelines, and global regulatory requirements/submissions; lead local product labeling and Core data sheet process while providing strategic regulatory guidance as an SME (4 yrs). Up to 30% travel required.
Apply on-line at www.takedajobs.com and search for Req # R0092069.
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its 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. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
Stock Symbol: TAK
650 East Kendall Street
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