Director, Global Regulatory Affairs CMC - Hybrid
Company: Takeda Pharmaceutical
Posted on: May 11, 2022
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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 DescriptionAt 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, Global Regulatory Affairs CMC where you will oversee the
development and execution of regulatory CMC development and
registration strategies. You may manage staff members. As part of
the Global Regulatory Affairs CMC team, you will work with
Regulatory, Pharmaceutical Development, and Production project
teams throughout clinical development and commercial lifecycle for
assigned products and staff.How you will contribute:
- Demonstrate Takeda leadership behaviors.
- Independently manage regulatory submissions for assigned
compounds in several phases of clinical development, global
marketing applications, and post-approval life cycle
- Participate in global teams that require experienced
interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to
ensure CMC compliance.
- Evaluate change proposals for regulatory impact and filing
- Lead team members that establish CMC content (data and
documentation) requirements for regulatory submissions and reviews
this content for conformance with established requirements.
- Lead and contribute to business process development.
- Evaluate new business development opportunities or represent
Global Regulatory Affairs CMC on due diligence teams.
- Maintain constructive relations with essential colleagues, e.g.
colleagues within Takeda, Alliance Partners, and Health Authority
- Ensure that project team colleagues, line management, and
partners are informed of developments that may affect regulatory
- Elevate and communicate actual or potential issues to line
- Successfully communicate and negotiate with international
Health Authorities, directly and indirectly.
- Represent Takeda Global Regulatory Affairs CMC in Health
Authority meetings and lead CMC preparation activities for meetings
with Health Authorities on CMC-related matters.
- Manage and support staff, if required, including staff
professional development and project oversight.What you bring to
- BS/BA Degree in a Scientific Discipline, Advanced Degree
- 10+ years pharmaceutical Regulatory CMC experience including
experience as an RA CMC product lead, or equivalent industry
experience, with international experience strongly preferred.
- Experience liaising 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
- Experience providing strategic regulatory guidance to drug
development, registration, and post-market support teams.
- Ability to deal with issues of critical importance, provides
regulatory advice and making reasoned decisions on regulatory
issues for which there may not be clear/specific regulatory
- Demonstrated leadership, problem-solving ability, flexibility
- Good judgement in elevating and communicating actual or
potential issues to line management.
- Excellent written and oral communication skills.
- Experience of active participation in Agency/Industry
groups/forums expected.Travel Requirements:
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.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.What Takeda can
- 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.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.#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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, New Rochelle , Director, Global Regulatory Affairs CMC - Hybrid, Executive , Bronx, New York
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