About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Senior Associate – Specialist, Global Regulatory Affairs CMC role is within in the GRA Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of critical functions as follows: 

• With supervision, support the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products. 

• Support RA CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. 

• With supervision, prepare  project plans and timelines for CMC submission activities and responsible for organization of CMC-relateddocuments for regulatorysubmissions.

• Expected to have a sound understanding of global RA CMC regulations and guidelines and participate in the development of strategies to enhanceprobability of regulatory success or enhancingregulatory compliance. Has ability to applythisunderstanding to support the development and execution of strategies to enhanceprobability of regulatory success and regulatory compliance.

• Sound analytical or processunderstandingthatenables the development of robust and accurate submissions.

• Assist in the coordination of communication and collaborationamonginternal and externalcolleagues.

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.