Responsibilities
* Responsibleforsupportingthe regulatory activities related to the development, registration and lifecycle management of vaccine candidates in Europe.
* Manages assigned regulatory projects including support of dossier/Marketing Authorization Application (MAA) submissions and lifecycle management for vaccine candidates in the region
* Ensure 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 counterpart 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 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.
* Supportsoverallcontentandmanagementoflocalregulatorycomponentsandfilingse.g.
* MAA,MAvariations.Contributestocontentforlocallabeldevelopment.
* 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 the vaccine 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 plus
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