Director, Regulatory Affairs & Quality Assurance - Mexico
authorizations, CMC variations, renewals, labeling updates, safety updates and post-approval commitments;coordinate responses...
authorizations, CMC variations, renewals, labeling updates, safety updates and post-approval commitments;coordinate responses...
tools such as Prisma, Fusion, New Era, PuTTY, Switch, IP Calculator, CMC, etc. Highly preferred. Experience in POS...
Düzenleyici gözetim (Reg-CMC kolaylastirma dahil)~ Özel durum yönetimi~ Tedarikçi Kalite yönetimi (yerel)~ Nitelik ve dogrulama...
du site (y compris la facilitation reg-CMC)~ Gestion des exceptions~ Gestion de la qualité des fournisseurs (local...
delle ispezioni~ Supervisione della regolamentazione del sito (incluso l'agevolazione Reg-CMC)~ Gestione delle eccezioni~ Gestione...
-functional stakeholders across business units such as Clinical, Pipeline, CMC, and other R&D functions. Prepare regulatory...
and other applicable systems ensuring accuracy and completeness of data/documents entered Collaborating with clinical, safety, CMC...