Associate Director, GRA CMC
Company: Takeda Pharmaceutical
Posted on: January 27, 2023
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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. 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 an Associate Director, Global Regulatory
Affairs CMC where you will be responsible and accountable for
Regulatory CMC development, registration and post-approval
strategies. You will communicate and negotiate with international
Health Authorities, directly and indirectly. You will ensure global
strategies are accomplished across both new product development and
existing portfolio life cycle management. 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
- Independently manage regulatory submissions for assigned
compounds in several phases of clinical development, global
marketing applications, and post-approval life cycle
- Member of global teams which require experienced interpretation
of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC
- Recommend direction for essential operations and new programs
in collaboration with local and global team members.
- Lead team members that establish CMC content (data and
documentation) requirements for regulatory submissions and reviews
this content for conformance with established requirement.
- Develop staff, if required, including staff professional
development and project oversight.
- Represent Takeda Regulatory Affairs CMC in Health Authority
meetings and lead preparation activities for meetings with Health
Authorities on CMC related matters.
- Interact directly with international Health Authorities.
Participate in and facilitate agency meetings.
- Ensure project team colleagues, line management, and partners
are informed of developments that may affect regulatory success.
Provide solutions to prevent recurrence of issues.
- Stay up-to-date with current and evolving regulatory CMC
requirements, apply this knowledge to assigned projects, and shares
experience with others to support their development.
- Maintain constructive relations with essential colleagues, e.g.
colleagues within Takeda, Alliance Partners, and Health Authority
- Evaluate new business development opportunities or participate
on due diligence teams.
- Evaluate change proposals for global regulatory impact and plan
global variations and amendments. Minimum
- BS/BA Degree in a Scientific Discipline, Advanced Degree
- 8+ 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).
- Experience with pharmaceutical development of active
pharmaceutical ingredient/drug substances or drug products,
analytical characterization, process scale-up or regulatory
registration of products is required.
- Experience with global regulatory aspects of CMC involving
undefined frameworks with medium technical complexity and defined
scope. Experience liaising with Regulatory Agencies having served
as lead in successful Agency Interactions related to CMC
submissions and product development meetings, international
- 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. Provide
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
- Demonstrate leadership, problem-solving ability, flexibility
and values teamwork.
- Demonstrated ability to work well within a matrix structure in
a complex environment.
- Exercise good judgement in elevating and communicating actual
or potential issues to line management and presents solutions to
- Excellent written and oral communication skills required.
- 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 reimbursementMore 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. This position is
currently classified as "hybrid" in accordance with Takeda's Hybrid
and Remote Work policy. Base Salary Range: $137,200 to $196,000
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 Off. 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. 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 Lexington, MA Worker Type Employee Worker Sub-Type
Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Trenton , Associate Director, GRA CMC, Executive , Trenton, New Jersey
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