stage 6 mois affaires réglementaires cmc vaccins
Core
Participate in the preparation of CMC dossiers for European and US authorities for new vaccines.
Role type
Regulatory Affairs Intern (CMC Vaccines)
Builds
CMC regulatory submissions for vaccines
Domain
Biopharmaceuticals / Vaccines / Regulatory Affairs
Required skills
Knowledge of Common Technical Document (CTD), IMPD guidelines, ICH guidelines, Analytical development processes
Responsibilities
Attend meetings with various teams, Implement regulatory strategy for new vaccines, Collaborate with technical experts to track analytical process development, Contribute to the drafting strategy of CMC dossiers
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