Director, Global Regulatory Affairs CMC - Biologics (Hybrid)
Posted on: November 20, 2023
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Join Takeda as a Director, of 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.
- Manage and lead a team to prepare 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 will
review this content for conformance with established
- 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
- 10+ years of pharmaceutical Regulatory CMC experience including
experience as an RA CMC product lead, or equivalent industry
experience, with international experience strongly
- 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 makes reasoned decisions on regulatory issues
for which there may not be clear/specific regulatory
- Demonstrated leadership, problem-solving ability, flexibility,
- Good judgment in elevating and communicating actual or
potential issues to line management.
- Excellent written and oral communication skills.
- Experience of active participation in Agency/Industry
- Willingness to travel to various meetings, including overnight
- Requires approximately up to 10-30% travel.
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, Boston , Director, Global Regulatory Affairs CMC - Biologics (Hybrid), Executive , Lexington, Massachusetts
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