Regulatory Affairs Manager jobs in Rochester, NY

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 and . I further attest that all information I submit in my employment application is true to the best of my knowledge.

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 and search for Req # R0092069.

EEO Statement

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.