Director, Global Regulatory Affairs, CMC Small Molecules
Company: Takeda
Location: Boston
Posted on: July 10, 2025
|
|
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 Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description 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. Join Takeda as a Director, GRA CMC Small Molecules where
you will oversee the development and execution of regulatory CMC
development and registration strategies. RA CMC member on
Regulatory, Pharmaceutical Development, and Production project
teams throughout clinical development and commercial lifecycle for
assigned products and staff. Demonstrate high level of leadership
and expert understanding of global RA CMC regulations and
guidelines by applying interpersonal skills and expert RA CMC
knowledge to address and overcome challenges that arise during
development and commercialization. You will also communicate and
negotiate with international Health Authorities as necessary,
directly and indirectly. Provide regulatory CMC expertise for new
business development/due diligence activities.Proactively
recognizes and contributes to enhancing business processes. As part
of the Global Regulatory Affairs CMC team, you will report to the
Senior Director Global Regulatory Affairs CMC. How you will
contribute: Independently plan, execute and manage regulatory
submissions for assigned compounds in various phases of clinical
development, global marketing applications, and post-approval life
cycle activities. Member of global cross-functional teams which
require experienced interpretation of applicable
EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance within
the organization. Lead team members that defines CMC content (data
and documentation) requirements for regulatory submissions and
reviews this content for conformance with established requirements.
Lead and/or contribute to business process development and
enhancement Evaluate new business development opportunities or
participate on due diligence teams. Develop and maintain
constructive relations with key internal and external colleagues,
e.g. cross functional colleagues within Takeda, Alliance Partners,
and Health Authority representatives. Responsible for ensuring that
project team colleagues, line management, and key stakeholders are
apprised of developments that may impact regulatory success,
exercising sound judgement and communicating in a professional and
timely manner. Exercise good judgement in elevating and
communicating actual or potential issues to line management.
Communicates and negotiates with international Health Authorities
as necessary, directly and indirectly. Represent Takeda RA CMC in
Health Authority meetings and leads or supports CMC preparation
activities for meetings with Health Authorities on CMC related
matters. Interact directly with international Health Authorities,
as required. Proven ability to liaise with Regulatory Agencies,
having served as lead in successful Agency Interactions related to
CMC submissions and product development meetings; international
experience preferred. Manage and develops staff, if required,
including staff professional development and project oversight
accountability. Evaluate change proposals for regulatory impact and
filing requirements. Minimum Requirements/Qualifications: BS/BA
Degree in a Scientific Discipline, Advanced Degree preferred. 10
years pharmaceutical Regulatory CMC experience including experience
as an RA CMC product lead with late stage development,
international experience strongly preferred. Significant Small
Molecule experience Proven ability to liaise with Regulatory
Agencies having served as lead in Agency Interactions and product
development meetings, international experience preferred.
Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
support. Proven ability to provide strategic regulatory guidance to
drug development, registration, and post-market support teams. Able
to deal with issues of critical importance, provides regulatory
advice and making reasoned decisions on regulatory issues for which
there may not be clear/specific regulatory guidance. Demonstrates
leadership, problem-solving ability, flexibility and teamwork.
Exercises good judgement in elevating and communicating actual or
potential issues to line management. Willingness to travel to
various meetings, including overnight trips. Requires approximately
up to 10-30% travel. More about us: At Takeda, we are transforming
patient care through the development of novel specialty
pharmaceuticals and best in class patient support programs. Takeda
is a patient-focused company that will inspire and empower you to
grow through life-changing work. Certified as a Global Top
Employer, Takeda offers stimulating careers, encourages innovation,
and strives for excellence in everything we do. We foster an
inclusive, collaborative workplace, in which our teams are united
by an unwavering commitment to deliver Better Health and a Brighter
Future to people around the world. LI-AA1 LI-Hybrid 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: $174,500.00 - $274,230.00 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. 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. 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. Locations Boston, MA Worker Type
Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes
It is unlawful in Massachusetts to require or administer a lie
detector test as a condition of employment or continued employment.
An employer who violates this law shall be subject to criminal
penalties and civil liability.
Keywords: Takeda, Plymouth , Director, Global Regulatory Affairs, CMC Small Molecules, Healthcare , Boston, Massachusetts