Senior Manager, Global Regulatory Affairs Cmc
vor 1 Woche
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 a Senior Manager, Global Regulatory Affairs CMC where you will develop and lead the execution of regulatory CMC investigational, registration and post-approval strategies for assigned products.
As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director or Director and work with Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.
How you will contribute:
- As a GRA CMC product leader or team member, ensures and enhances regulatory compliance for filing requirements for assigned compounds throughout development and the commercial life cycle.
- Independently define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- With moderate guidance, represents Takeda RA CMC in Health Authority meetings and leads CMC preparation activities for meetings with Health Authorities on CMC related matters.
- Interact directly with international Health Authorities.
- Ensure project team colleagues, line management, and partners are informed of developments that may affect regulatory success.
- Foster constructive working relationships when working with all colleagues.
- Evaluate change proposals for global regulatory impact. and plans global variations and amendments.
What you bring to Takeda:
- BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.
- 6+ 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).
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and postmarket support.
- Experience providing strategic regulatory guidance to drug development, registration, and postmarket support teams.
- Able to deal with issues of essential importance. Provide regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Demonstrate new leadership, problemsolving ability, attention to detail, flexibility and values teamwork.
- Exercise good judgement in elevating and communicating actual or potential issues to line management.
- Excellent written and oral communication skills.
- Active participation in Agency/Industry groups/forums preferred.
Locations:
AUT - Wien - DC Tower
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
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