Senior Manager, Global Regulatory Affairs CMC
Company: Takeda Pharmaceutical
Location: Malden
Posted on: May 9, 2022
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 DescriptionAbout 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 Senior Manager, Global Regulatory Affairs CMC where you
will develop and lead the execution of regulatory CMC
investigational, registration and post-approval strategies for
assigned products. You will also with moderate guidance,
communicate and negotiate with international Health Authorities,
directly and indirectly. As part of the Global Regulatory Affairs
CMC team, you will work with Regulatory, Pharmaceutical
Development, and Commercial project teams throughout clinical
development and commercial lifecycle.How you will contribute:
- Plan and execute regulatory submissions for assigned compounds
in several phases of clinical development, global marketing
applications, and post-approval life cycle activities.
- As a GRA CMC product leader or team member, ensures and
enhances regulatory compliance for filing requirements for assigned
compounds throughout development and the commercial life
cycle.
- Independently define CMC content (data and documentation)
requirements for regulatory submissions and reviews this content
for conformance with established requirement.
- With moderate guidance, represents Takeda RA CMC in Health
Authority meetings and leads CMC preparation activities for
meetings with Health Authorities on CMC related matters.
- Interact directly with international Health Authorities.
- Ensure project team colleagues, line management, and partners
are informed of developments that may affect regulatory
success.
- Foster constructive working relationships when working with all
colleagues.
- Evaluate change proposals for global regulatory impact. and
plans global variations and amendments.What you bring to Takeda:
- BS/BA Degree in a Scientific Discipline, Advanced Degree
preferred.
- 6+ years pharmaceutical Regulatory CMC experience, including
experience as an RA CMC product lead, or equivalent industry
experience. (e.g., Pharmaceutical Development, Analytical
Development, Production, Quality Assurance).
- Understanding of scientific principles and regulatory CMC
requirements relevant to global drug development and post-market
support.
- Experience providing strategic regulatory guidance to drug
development, registration, and post-market support teams.
- Able to deal with issues of essential importance. Provide
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
guidance.
- Demonstrate new leadership, problem-solving ability, attention
to detail, flexibility and values teamwork.
- Exercise good judgement in elevating and communicating actual
or potential issues to line management.
- Excellent written and oral communication skills.
- Active participation in Agency/Industry groups/forums
preferred.What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and
Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and
health screenings
- Generous time off for vacation and the option to purchase
additional vacation days
- Community Outreach Programs and company match of charitable
contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursementThis position is currently classified as
"hybrid" in accordance with Takeda's Hybrid and Remote Work
policy.In accordance with the CO Equal Pay Act, -Colorado
Applicants Are Not Permitted to Apply.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.Empowering our people
to shine: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.No Phone Calls or Recruiters Please.#LI-LC1EEO 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.LocationsLexington, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Malden , Senior Manager, Global Regulatory Affairs CMC, Executive , Malden, Massachusetts
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