Director, Global Regulatory Affairs CMC - Hybird
Company: Takeda Pharmaceutical
Posted on: November 22, 2022
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to the best of my knowledge.Job DescriptionJob 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
- 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.Base Salary Range: $156,800 to $224,000
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. -In accordance with the CO Equal Pay
Act, Colorado Applicants Are Not Permitted to Apply.EEO
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.LocationsLexington, MAWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Newark , Director, Global Regulatory Affairs CMC - Hybird, Executive , Newark, New Jersey
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