Senior Manager, Global Regulatory Affairs CMC
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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 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
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
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
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
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
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
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
Family Planning Support
Flexible Work Paths
This 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
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
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.
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.
Keywords: Takeda Pharmaceutical, Paterson , Senior Manager, Global Regulatory Affairs CMC, Executive , Sussex, New Jersey
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