Aktualne oferty pracy związane z CMC Regulatory Specialist - Warszawa, Mazovia - GlaxoSmithKline
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European Compliance Specialist Role
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Regulatory Affairs Manager
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senior manager regulatory affairs
4 tygodni temu
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Post-Approval Regulatory Expert
4 dni temu
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Regulatory Affairs Manager Role
4 dni temu
Warszawa, Mazovia, Polska TN Poland Pełny etatAbout the JobWe are seeking an experienced regulatory professional to join our dynamic team as a CMC Regulatory Manager. This client-dedicated project offers flexibility, with the option to work from home or office in various European locations.As the CMC Regulatory Manager, you will play a key role in our company's worldwide post-approval regulatory...
CMC Regulatory Specialist
1 tydzień temu
GRC Regulatory Affairs Professional
The Renewals CMC Team within the Global Regulatory Centres (GRC) is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. We are seeking a highly skilled Regulatory Specialist with expertise in Chemistry, Manufacturing, and Controls (CMC).
Key Responsibilities:
- Evaluate and implement innovative solutions for CMC regulatory processes, policies, and systems.
- Manage multiple CMC renewals assignments for pharmaceutical and vaccines products, including response to questions from regulatory agencies.
- Collaborate with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies worldwide to deliver high-quality dossiers on time.
- Act as subject matter expert in regulatory processes and monitor regulatory intelligence.
Job Requirements
- Relevant degree or equivalent experience in regulatory affairs, chemistry, or a related field.
- Proven track record in managing CMC regulatory submissions and responding to agency queries.
- Excellent communication and collaboration skills.
Benefits
We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.