Senior Manager, Global Regulatory Affairs CMC
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 25, 2023
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
that all information I submit in my employment application is true
to the best of my knowledge.
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 report to the Senior Director or Director and
work with Regulatory, Pharmaceutical Development, and Commercial
project teams throughout clinical development and commercial
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
- 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
- Foster constructive working relationships when working with all
- Evaluate change proposals for global regulatory impact. and
plans global variations and amendments. Minimum
- BS/BA Degree in a Scientific Discipline, Advanced Degree
- 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
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
- 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
- Tuition reimbursement
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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy.
Base Salary Range: $124,600- $178,000, based on candidate
professional experience level. Employees may also be eligible for
Short Term and Long-Term Incentive benefits as well. Employees are
eligible to participate in Medical, Dental, Vision, Life Insurance,
401(k), Charitable Contribution Match, Holidays, Personal Days &
Vacation, Tuition Reimbursement Program and Paid Volunteer Time
The final salary offered for this position may take into account a
number of factors including, but not limited to, location, skills,
education, and experience.
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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.
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, Cherry Hill , Senior Manager, Global Regulatory Affairs CMC, Executive , Cherry Hill, New Jersey
Didn't find what you're looking for? Search again!