Cmc Regulatory Affairs Associate Director
il y a 6 jours
Nous recherchons pour l’un de nos clients : une Biotech un Directeur associé CMC (AR).
Vos missions:
- Assister et participer aux équipes de projet de la sous-équipe, de l'équipe principale et de la BLA.
- Vous êtes en charge de l'organisation et de la mise en œuvre de l'ensemble des activités de l'entreprise, de la conception à la mise en œuvre, en passant par le suivi et l'évaluation.
- Rédiger et/ou réviser, et éditer les CMC réglementaires et autres documents à l'appui des IND, BLA et autres soumissions réglementaires.
- Fournir des mises à jour régulières à la direction interfonctionnelle concernant les produits livrables, le projet, le calendrier et le budget.
- Evaluer l'impact réglementaire des contrôles de changement et notifier les changements aux autorités réglementaires.
- Développer et proposer la stratégie réglementaire en matière de CMC (pour répondre aux questions des autorités sanitaires).
- Point de contact réglementaire CMC pour les autres départements en ce qui concerne les sujets réglementaires CMC.
Vous disposez d’au moins 7 ans d'expérience dans une entreprise de biotechnologie en pleine croissance. Vous avez une compréhension approfondie et démontrée des exigences de la FDA et de la CMC aux Etats-Unis pour le développement de produits combinés (médicament/dispositif ; produit biologique/dispositif). Vous parlez anglais couramment. Une compréhension et expérience des processus réglementaires de l'EMA de l'UE est un plus. #1341201
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Senior Manager CMC Regulatory
il y a 5 jours
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Senior Manager CMC Regulatory
il y a 4 jours
Paris, Île-de-France Ipsen Temps pleinPOSITIONJob TitleSenior Manager, CMC Regulatory Strategy BiologicsDivision / FunctionGlobal Regulatory Affairs (GRA)Manager's Job TitleDirector/Sr Director CMC Regulatory Strategy BiologicsIpsen Job ProfileRegulatory CMCLocation:Paris, FR & Paddington, UKWHAT - Summary & Purpose Of The PositionResponsibility for CMC regulatory strategy for the assigned...
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Senior Manager CMC Regulatory
il y a 5 jours
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Biologics CMC Regulatory Strategy Lead
il y a 5 jours
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il y a 6 jours
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il y a 2 jours
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Paris, France Ipsen Innovation (SAS) Temps pleinThe position offers a 12-month apprenticeship in Global Regulatory Affairs, CMC Regulatory strategy, Biological products and reports to the Senior Director, Senior Manager or Manager in GRA CMC Regulatory Strategy. **Here are your responsabilities**: **Regulatory coordination** - Participate to the CMC regulatory strategy liaising with cross functional...
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il y a 2 semaines
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