...in Poland is creating new roles in the Product Variations team. The purpose for the roles will be leading and participating in global CMC (Chemistry, Manufacturing and Control) variation projects as well as in the Global Supply Chain (GSC) centrally driven change...
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Praca zdalna
Praca zmianowa
Elastyczny czas pracy
GlaxoSmithKline
Warszawa
3 dni temu
...resource assignment and scope discussions/decisions.
Identify gaps / areas for clarification to be raised with stakeholders (e.g. CMC & Global Labeling, EMEA TA, LOCs and other ERMC team members). Liaise with stakeholders as agreed to collect input/clarification for...
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Praca hybrydowa
Praca zdalna
...Professional with some work experience in Regulatory Affairs/Pharmaceutical industry (minimum 1 year and preferably with an understanding of CMC documentation/Module 3). It is expected that you will be eager to learn, have good interpersonal skills and problem-solving...
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Elastyczny czas pracy
...1183618
Key responsibilities:
Preparing registration submissions and post-approval variations for medicinal products
Managing CMC (Chemistry, Manufacturing and Control) Variations for Finished Products and Active Pharmaceutical Ingredients
Maintaining Product...
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...implementation of the change in the applicable databases and, if applicable, artwork.
Coordinate lifecycle management procedures (mostly CMC variations and Labeling changes) plus any other regulatory procedure as assigned.
Coordinate procedures from planning (assignment...
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Praca hybrydowa
Praca zdalna
...submissions as required.
Interact with the cross-functional team (Regulatory, Clinical Development, Clinical Operations, Safety, CMC) incl. CRO team representatives to ensure optimal execution of the agreed regulatory strategy for development medicinal products
Maintains...
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Praca na pełen etat
Legalna praca
Moderna Therapeutics
Warszawa
2 dni temu