Lavori attuali relativi a Regulatory affairs - Milano - Page Personnel

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    Milano, Lombardia, Italia Page Personnel A tempo pieno

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  • Regulatory Affairs Manager

    1 mese fa

    Milano, Italia Meet Recruitment Limited A tempo pieno

    Global Regulatory Affairs ManagerWe're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products.Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Manager will be responsible for...

  • Stage Regulatory Affairs

    4 settimane fa

    Milano, Italia Dompé Farmaceutici S.P.A. A tempo pieno

    Select how often (in days) to receive an alert:Stage Regulatory AffairsJob Area: R&D/MedicalJob Category: InternshipsJob Site: On SiteLocation: Milano, ITFor our company in Milan (Italy), we are looking for a Stage Regulatory Affairs.The Intern will support the Regulatory Affairs Team in the following activities related to Primary & Specialty Care and...

Regulatory affairs

3 mesi fa

Milano, Italia Page Personnel A tempo pieno
  • Regulatory affairs
  • Pharmaceutical Company
Il nostro clientePharmaceutical Company , located in Hinterland MilanRuoloMain responsibilities:

Managing and preparation of regulatory dossier (CTD) for submissions of human drug substances (Applicant and Restricted part) for US, EU and extra-EU submissions.

Preparation and management of dossiers (Modules 1-2-3) following deficiency letters sent by authorities and following the applicable changes.

Managing and preparations of Renewals and annual report.

Evaluation of changes.

Support, tracking and management of customer's variations.

Support to regulatory strategy for Investigational Medicinal Products (IMPD).

Support to SOP's evaluation and editing.Il candidato presceltoThe resource must have:
- degree in scientific subjects
- Regulatory experience in a pharmaceutical companyCosa comprende l'offertaImportant career opportunityJob ref: JN