Senior CMC Regulatory Affairs Manager
2 weeks ago
Vi söker en Senior CMC Regulatory Affairs Manager till vårt team på BioArctic AB. Du kommer att ha det övergripande ansvaret för att planera, författa och hantera dokumentation relaterad till Chemistry Manufacturing and Control (CMC) för att uppfylla globala regulatoriska krav. Rollen innebär starkt stöd och vägledning till tvärfunktionella team och att säkerställa att vi uppfyller alla regulatoriska krav.
Arbetsuppgifter
- Utveckla och implementera CMC-regulatoriska strategier för våra projekt
- Ansvara för författande och koordinering av CMC-dokumentation för regulatoriska inlämningar och svar på förfrågningar
- Organisera och delta i möten med regulatoriska myndigheter
- Stödja CMC- och QA-avdelningar i aktiviteter kopplade till globala regulatoriska krav och interna kvalitetsförbättringar
- Säkerställa hög kvalitet på dokumentation och minska regulatoriska risker
- Hålla sig uppdaterad med nya CMC-relaterade föreskrifter och utbilda kollegor
- Ad-hoc stöd till CMC-funktionen när arbetsbelastning tillåter
Kvalifikationer
- Universitetsutbildning inom relevant naturvetenskapligt ämnesområde
- Minst 10 års erfarenhet av regulatoriska CMC-projekt, från tidig till sen utvecklingsfas
- Erfarenhet av att förbereda regulatorisk CMC-dokumentation för kliniska prövningar (IMPD, IND Module 3-dokumentation)
- Djup kunskap om CMC-utveckling av biologiska läkemedel och Good Manufacturing Practices (GMP)
- Mycket god förmåga att kommunicera muntligt och skriftligt på engelska
Meriterande
- Erfarenhet av projekt runt sällsynta sjukdomar
- Erfarenhet av accelererade godkännandeprocesser i EU och USA
- Erfarenhet av globala kliniska prövningar
- Erfarenhet av att arbeta med Contract Development Manufacturing Organizations (CDMOs)
Hos oss får du möjlighet att arbeta i en dynamisk miljö med engagerade kollegor och spännande projekt. Om du är en driven och kompetent person som vill göra skillnad, välkommen att skicka in din ansökan.
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Vi ber vänligen att rekryterare avstår från att kontakta BioArctic angående denna tjänst. Vi hanterar hela rekryteringsprocessen internt.
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