Regulatory Affairs Manager

Job Description

Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:

1. Master’s degree in Regulatory Affairs or related field plus 2 years of related experience.

Prior experience must include:

1. Developing regulatory submission strategies for products in commercial and development phases by working closely with quality, manufacturing, and global regulatory teams.
2. Ensuring timely and efficient responses to health authority queries by collaborating with regulatory teams across different regions.
3. Submitting compliance submissions such as annual reports (BLA), yearly biologic periodic reports, and license renewals to ensure marketed products comply with Health Authority requirements.
4. Providing regulatory assessments for change controls for various markets such as US FDA, EMA, and Health Canada, and liaising with in-country regulatory representatives to provide these assessments.

Up to 20% remote work allowed.

Apply online and search for Req #R0119855.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:
Boston, MA

U.S. Base Salary Range:
$133,000.00 - $209,000.00
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.