Associate Director (m/f/d) - Regulatory Affairs Vaccine (RAV) Europe

at  Takeda Pharmaceutical

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JOB DESCRIPTION

At our heart we are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, sexual orientation, race, color, ethnic or social origin, or disability.
Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

• 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 Authorization Application (MAA) submissions and life cycle management for vaccine candidates in the region
• Ensures 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 regulations.
• Responsible for regulatory oversight of assigned clinical trials conducted in the region.
• 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.
• Close collaboration with the RAV Europe Region Head (and Local Operating Company (LOCs) RA 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 (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-first-time.
• Supports 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 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 in the preparation of health authority interactions/meetings in the region as applicable for specified projects
• Actively participate as member of teams within RAV supporting activities as assigned.
• Manages specific projects as assigned.
• Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.