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Gestionnaire des affaires réglementaires/in

GSK Vaccines GmbH Numéro de référence: 10000-1189682088-S
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Langue / Candidature en:Marburg (Hesse) Horaires de travail: Temps plein Type de contrat: Open-ended Taille de l'entreprise: Entre 501 et 5 000

‘Be You’ at GSK
Are you looking for an exciting opportunity to progress in your career in regulatory affairs? Do you have a background in manufacturing, validation and quality management? If so, this is the role for you.
Regulatory Affairs Manager (m/f/d)
Job Purpose:
Ensures all Facilities & Equipment regulatory activities of assigned projects required to ensure product development or maintenance of compliant supply worldwide are carried out in compliance with evolving regulations. Ensure that all aspects of the handling, manufacturing and distribution of Vaccine products at the site comply with the requirements of the respective valid quality manual/QMS and policies and meet all relevant cGMP regulatory and legislative requirements
• Responsible for the global CMC regulatory activities associated with facilities and equipment for assigned projects and respond readily to changing events and priorities.
• Responsible for CMC strategy development managerial suport and creation of CMC submission documents for facilities and equipment from early phase clinical submissions (IND/IMPD) through to marketing applications (NDA/BLA/MAA) and commercial lifecycle management activities in accordance with the applicable regulatory & scientific standards.
• Understands, interprets, and will sometimes advise teams on regulations, guidelines, procedures and policies relating to facilities and GMP requirements to expedite the submission, review and approval of global CMC applications
• Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership to define proper regulatory CMC filing strategy for facilities and equpment
• Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
• Engages in Subject Matter Expert activities internally (for increased compliance, harmonization, and efficiency)
• Will sometimes deliver CMC regulatory strategy to support major inspections (e.g. PAI's) with managerial support
• Formulates novel approaches and influences people, systems, and processes
• Identifies risks associated with submission data and information packages.
• Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, policies, and systems
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
• University degree (Master, Diploma, PhD) in natural sciences, bio science, bio technologies, pharmacy, or other related disciplines
• Fluent in German and English
• Regulatory Affairs Facilities & equipment experience with direct involvement in regulatory submission preparation across all stages of development, licensing through to life cycle submissions
• Sound knowledge of drug development, manufacturing, supply processes
• Knowledge of worldwide Facilities and GMP regulatory requirements and successful track record of delivering dossiers that comply with these
• Good time management skills with the ability to effectively plan, prioritize and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
• Routine audience is GSK Management and departmental / same specialism -
• May contribute to efforts to influence the internal/external CMC Regulatory and/or R&D/Production/QC/QA environment

Vous avez des questions sur la candidature et la recherche d'emploi ? L'Agence fédérale pour l'emploi (BA) vous apporte un soutien personnalisé sur tous les thèmes liés au travail en Allemagne.



Questions et candidatures adressées à: GSK Vaccines GmbH
Personne à contacter: M. Tom Sobilo

À joindre: Geforderte Anlagen: Lebenslauf, Zeugnisse

Nos offres d'emploi s'adressent toujours à toutes les personnes capables de travailler, quels que soient leur âge, leur sexe, leur origine, leur orientation sexuelle, leur handicap, leur religion et leur idéologie, etc. Les candidats sont exclusivement sélectionnés sur la base de leurs qualifications. Les erreurs dans les informations données et l'orthographe sont réservées.

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