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Directeur des affaires réglementaires (Pharma/Sciences de la vie)

AiCuris Anti-infective Cures AG Numéro de référence: 10000-1189219809-S
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Langue / Candidature en: Englisch Wuppertal (Rhénanie-du-Nord-Westphalie) Horaires de travail: Temps plein Type de contrat: Open-ended Taille de l'entreprise: Entre 51 et 500

The Senior Expert Regulatory Affairs will support the development team by bringing products from research through the clinical development phases 1–3. Specifically, the position will supervise the execution of clinical trials and will also be in charge regarding the best road map as well as of contacting relevant regulatory authorities at the right time. In addition, the Senior Expert will facilitate authority meetings and prepare the necessary briefing packages containing a full development strategy. On the whole, the role will be responsible for the interaction with regulatory authorities in all phases including dossier preparation and full regulatory submissions.


Responsibilities
• Provide significant input and guide the development team on regulatory requirements, and develop regulatory strategies during development of new drug products
• Evaluate documentation on Quality, Efficacy, Safety on the basis of existing rules and regulations
• Contact and communicate with authorities
• Provide regulatory assessment during due diligences
• Provide information on proposed/current FDA/EMA regulations and guidelines for assigned products/projects to the team
• Work with consultants related to the development activities

AGENCY INTERACTIONS:
• Responsible for agency contact and interaction
• Prepare and lead the team during preparation and conduct of agency meetings (e.g., FDA, EMA, BfArM)

SUBMISSIONS:
• Plan, coordinate and supervise all types of submissions to regulatory agencies for assigned products/projects
• Facilitate and organize the compilation of applications (IND, NDA, BLA, CTA, MAA) to regulatory agencies for development products; maintain up-to-date knowledge of the data, information and formats required for inclusion in these applications
• Review summaries or reports from contributing departments, and provide comments to assure accurate and complete documents for inclusion in applications
• Coordinate writing of documents like IMPD, IB, DSUR or individual modules of the CTD (Quality Summary, Nonclinical and Clinical Overview and Summaries)


Skills and qualification
• Bachelor/Life Science degree; master's degree in Drug Regulatory Affairs preferred
• 5 years regulatory experience in drug development in the pharmaceutical industry
• Experience and knowledge of the current requirements in US and Europe, Asian agencies as a plus
• Excellent communication, team working and leadership
• Good organizational, communication and intercultural skills
• Flexible, scientific working style and willingness for continuous education
• Fluency in English


What we can offer
• Cooperation in multinational and interdisciplinary teams
• An exciting field of activity in a promising research and development company
• Flexible working hours and self-determined time management
• Flexible combination of on-site work and mobile working
• Regular and targeted further training and individual development opportunities
• Attractive remuneration and company pension scheme
• A wide range of offers in terms of health and reconciling work and family life

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.

Contactez-nous

Coordonnées

Questions et candidatures adressées à: AiCuris Anti-infective Cures GmbH
Personne à contacter: Mme Daniela Boshoven

E-Mail: jobs@aicuris.com
À joindre: Geforderte Anlagen: Lebenslauf, Zeugnisse

  • AiCuris Anti-infective Cures AG
  • Friedrich-Ebert-Str.
  • 42117 Wuppertal
  • Téléphone: +49 202 317632599

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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