Manager, Regulatory Affairs CMC
Company: Takeda Pharmaceutical
Location: Boston
Posted on: April 30, 2024
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Job Description:
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.Job DescriptionTakeda 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: Develop the regulatory submission
strategies for products in commercial and development phase by
working in close coordination with the quality, manufacturing and
global regulatory teams; Ensure the response to health authority
queries are provided in a timely and efficient manner by working
with regulatory teams across different regions; Submit the
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; Provide regulatory assessments for change
controls for various markets such as US FDA, EMA, Health Canada as
well as liase with in-country regulatory representative to provide
the assessments. Up to 20% remote work allowed.Apply on-line at and
search for Req #R0119855.Takeda Compensation and Benefits SummaryWe
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, MAU.S. Base Salary
Range:$133,000.00 - $209,000.00The 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-term incentives. 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. -EEO StatementTakeda 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
Keywords: Takeda Pharmaceutical, Arlington , Manager, Regulatory Affairs CMC, Executive , Boston, Massachusetts
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