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](
DLLX0uEHXJvU8nOHrUK8IrwNKOtkVU&r=R7Z8seTzCwqpIAi7APe73INoZm9-sxCdHQKjwfWPCQs&m=dHDH9k7lo2jkh-
wOGxeg4p4mAfV8Vr_FCuR60MDlbTo&s=Tj67ufwJLuB1vZlHjecELumJYbWpaHHiC9kI2nnRDKU&e=)
and [Terms of
Use](
DLLX0uEHXJvU8nOHrUK8IrwNKOtkVU&r=R7Z8seTzCwqpIAi7APe73INoZm9-sxCdHQKjwfWPCQs&m=dHDH9k7lo2jkh-
wOGxeg4p4mAfV8Vr_FCuR60MDlbTo&s=_CIJE9CeroUy1ZLHeCKCoxM1jCAPZSz9Vq5yEGoRCGg&e=).
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 developmentdue 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 EMAFDAICHWHOGlobal 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 andor 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 RequirementsQualifications:
- BSBA 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 clearspecific 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-RM1
**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:**
169,400.00 - 266,200.00
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 andor 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 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.
Job Tags
Holiday work, Full time, Temporary work, Local area, Worldwide, Night shift,