Regulatory Affairs Manager
vor 24 Stunden
Contract Start Date: 02/03/2026Contract End Date: 31/08/2026Requires approximately 10 % travelResponsibilities:Responsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.Manages assigned regulatory projects including support of dossier/Marketing AuthorizationApplication (MAA) submissions and life cycle management for vaccine candidates in the regionEnsures that all necessary applications are filed and maintained in compliance with applicable regulations.Responsible for regulatory oversight of assigned clinical trials conducted in the region.Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.Collaborates with all Takeda regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.Leads and directs the work of others as part of a matrixed organization.Close collaboration with the RAV Europe Region Head and Lead (and LOCs as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.In cooperation with key stakeholders and RAV Europe Region Head/Lead (and LOCs asapplicable), is responsible for overall content, management, compilation and timelyavailability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements.Supports overall content and management of local regulatory components and filings e.g.MAA, MA variations. Contributes to content for local label development.Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.Supports RAV Europe Region Head/Lead in the preparation of health authority interactions/meetings in the region as applicable for specified projects.Responsible for managing of submission components in the Electronic Document Management system (EDMS).Responsible for filing and archiving of regulatory relevant documentations/HA.Requirements:Bachelor's Degree preferred.A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 6 years regulatory and/or related experience in thevaccine area.Preferred experience in managing filings to EMA via Centralised Procedure resulting in first time approval; or managing multiple programs in closely related development area.Vaccines and/or biologics experience is essential.Participation in Global regulatory filing a plus
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Regulatory Affairs Manager
vor 1 Woche
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