Odgovoren za regulativne dejavnosti, posebej povezane s kemijo, proizvodnjo in nadzorom (CMC). Dejavnosti, kot sta priprava in objava dokumentacije REG CMC za predložitev zdravstvenim organom. Poleg tega interakcija s ha-jev na REG CMC vprašanja za podporo novih proizvodov ali post trženih izstrelitev.
About The Role
Major Accountabilities
~ Razvoj, podpiranje in prenos celovite regulativne strategije CMC, ki spodbuja strokovno znanje celovitih predpisov, da se osredotoči na inovacije in poveča učinkovitost poslovanja, hkrati pa uravnotežijo regulativna tveganja in skladnost.
~ Upravljajte in podpirajo vse globalne dejavnosti skladiščenja MCC (načrtovanje, ustvarjanje, vrednotenje, usklajevanje, skladiščenje) za izvajanje celovite strategije ponujanja.
~ Glede na urnik projekta je odobren izvirni dokument predviden za zagotavljanje dokumentacije, kakovosti in/ali časa za globalne spore in pogajanje.
~ Z oddelkom za zdravje se posvetujemo, da bi zbrali visokokakovostne dokumente CMC ter opredelili in izvajali globalne regulativne strategije MCC, trenutne trende in regulativne politike.
~ Med drugimi udeleženci projektne skupine dejavno spodbujajo ključne strategije, tveganja, izzive in življenjske kroge prek splošnih odborov in več odborov na terenu.
~ Vodnik, pisanje in poročanje o izkušnjah, pridobljenih iz ocene tveganja MCC, načrtov za obvladovanje tveganja, prispevkov ali pomembnih poročil.
~ Dialogi in sestanki ter načrti, specifični cilji, novi, dokazani in načrtovani ter Blažilni načrti.
~ Z našim strokovnim delom nudimo strateško svetovanje in svetovanje oddelku ter zagotovimo dosledno delovanje.
~ Delite svoje znanje o neizkušenih članov CMC ra in pravila.
~ Poročanje o tehničnih pritožbah / neželenih dogodkih / scenarijih posebnih primerov, povezanih z Novartis izdelki v roku 24 ur po prejemu
~ Distribucija vzorcev trženja (kjer je primerno)
Key Performance Indicators
Odgovoren za regulativne dejavnosti, posebej povezane s kemijo, proizvodnjo in nadzorom (CMC). Dejavnosti, kot sta priprava in objava dokumentacije REG CMC za predložitev zdravstvenim organom. Poleg tega interakcija s ha-jev na REG CMC vprašanja za podporo novih proizvodov ali post trženih izstrelitev.
Work Experience
~Vodenje operacij in izvrševanje
~Vodenje projektov
~Sodelovanje prek meja
~Funkcionalna širina
~Medkulturne izkušnje
~Obvladovanje kriznih situacij
~Pomembna pogajanja
Skills
~Spremeni nadzor
~Razvoj zdravil
~Vede o življenju
~Pogajalske spretnosti
~Farmacevtski izdelki
~Upravljanje življenjskega cikla izdelka (Plm)
~Skladnost s predpisi
~Upravljanje s tveganji
~Vodenje projektov
Language
Angleščina
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