Senior Manager - Regulatory Affairs Vaccine Europe

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TasksResponsible for supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in EuropeManages assigned regulatory projects including support of dossier/Marketing Authorization Application submissions and life cycle management for vaccine candidatesEnsures that all necessary applications are filed and maintained in compliance with applicable regulations.Provides regulatory operational support for assigned projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulationsResponsible for regulatory oversight of assigned clinical trials conducted in the regionCollaborates with all regulatory counterparts to ensure alignment and execution of the global regulatory strategy for the assigned projects.Passion for quality in all areas of responsibilityLeads and directs the work of others as part of a matrixed organization.Close collaboration with the Regulatory Affairs Vaccine Europe Region Head (and local operating company RA as applicable) to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle managementIn cooperation with key stakeholders and RAV Europe Region Head (and LOC RA as applicable), is responsible for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned region/countries, ensuring filings meet local regulatory requirements. Has a quality focus so that submissions are right the first timeSupports overall content and management of local/regional regulatory components and filings e.g. MAA, MA variations. Contributes to local/regional label development and submission.Ensures compliance with both internal 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 in the preparation of health authority interactions/meetings in the region as applicable for specified projectsActively participate as member of teams within RAV supporting activities as assignedResponsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team membersSthree Switzerland is acting as an Employment Business in relation to this vacancy.