Manager, Regulatory Affairs Vaccine (RAV) Emerging Markets応募 後で応募 求人ID R0009061 掲載日 06/13/2019 Location:Zurich, Switzerland
- Responsible for supporting the regulatory activities related to the development and registration of the vaccine candidates in the Emerging Markets (EM) Region.
- Interact with the regulatory teams at the Local Operating Companies (LOCs) to ensure successful submission, approval and commercialization of vaccine candidates in the EM countries.
- 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.
- Passion for quality in all areas of responsibility
- Leads and directs the work of others as part of a matrixed organization.
- Responsible for filing and archiving of regulatory relevant documentations/HA communications in compliance with Takeda SOPs.
- Close collaboration with the EM Region Head and/or, Area Leads and LOCs to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.
- In collaboration with the regulatory teams at LOCs, responsible for the identification, compilation and communication of any specific regulatory requirements and new regulation in the assigned region, which could impact vaccine activities. Close alignment with Area Leads in order to ensure specifics requirements/regulations are considered in due time in VBU projects.
- In cooperation with key stakeholders and Area Leads, is accountable for overall content, management, compilation and timely availability of CTD Module 1 regulatory components to the assigned countries/region. Has a quality focus so that submissions are right-first-time.
- 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.
- Support Area Lead/EM Region Head in the preparation of health authority/WHO meetings as applicable for specified projects
- Actively participate as member of Global Regulatory Teams supporting products activities as assigned.
- Manages specific projects as assigned, e.g. activities related to Regulatory Affairs Vaccines TMF Oversight.