Regulatory Affairs Officer
- Puurs
My clients Regulatory & Product Support Department is seeking a dynamic Regulatory Associate to join their team. You will work in cross-functional teams with different Puurs departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site. * You support regulatory submissions (CTD, BLA) of the products by informing site colleagues of regulatory requirements and by authoring the dossier, for review with GCMC. In this regulatory role you interact on a daily basis with several Puurs departments (manufacturing, labs, QA, supply,…). * You assess Post approval changes at the manufacturing site and the associated regulatory variations.
My clients Regulatory & Product Support Department is seeking a dynamic Regulatory Associate to join their team. You will work in cross-functional teams with different Puurs departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site. * You support regulatory submissions (CTD, BLA) of the products by informing site colleagues of regulatory requirements and by authoring the dossier, for review with GCMC. In this regulatory role you interact on a daily basis with several Puurs departments (manufacturing, labs, QA, supply,…). * You assess Post approval changes at the manufacturing site and the associated regulatory variations.
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