Regulatory Affairs Manager
6 days ago
Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements:
- Master's degree in Regulatory Affairs or related field plus 2 years of related experience.
Prior experience must include:
- Developing the regulatory submission strategies for products in commercial and development phases by working in close coordination with the quality, manufacturing, and global regulatory teams;
- Ensuring the response to health authority queries are provided in a timely and efficient manner by working with regulatory teams across different regions;
- Submitting compliance submissions such as annual reports (BLA), yearly biologic periodic reports, and license renewals in a timely manner to ensure the marketed products are in compliance with Health Authority requirements;
- Providing regulatory assessments for change controls for various markets such as US FDA, EMA, Health Canada, as well as liaising with in-country regulatory representatives to provide the assessments.
Up to 20% remote work allowed.
Apply on-line at and search for Req #R0119855.
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.
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