Director, Global Regulatory Affairs CMC - Hybrid
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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, 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
Independently manage regulatory submissions for assigned compounds
in several phases of clinical development, global marketing
applications, and post-approval life cycle activities.
Participate in global teams that require experienced interpretation
of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC
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 Takeda: BS/BA Degree in a Scientific Discipline,
Advanced Degree preferred.
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 and
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
Travel Requirements: Willingness to travel to various meetings,
including overnight trips.
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 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
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.
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, Bethlehem , Director, Global Regulatory Affairs CMC - Hybrid, Executive , Clinton, Pennsylvania
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