Associate Director, Regulatory Affairs Vaccines

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Job Description

**Proficiency in local language is required**

About the role:

• Support regulatory activities related to the development, registration and lifecycle maintenance (LCM) of the Takeda vaccine candidates in the International Regions, specifically LATAM countries.

• Interact with the regulatory teams at the Local Operating Companies (LOCs) to support the development of innovative and effective regulatory strategies for initial filing and maintenance, and ensure successful execution of the defined strategy for submission, approval and commercialization of vaccine candidates.

• Provide operational and strategic input to Regional and Global cross-functional teams.

• Ensure effective communication, collaborative and constructive working relationships with all relevant stakeholders (RAV International Regions Team, LOCs, regional, Global cross-functional teams, etc.).

How you will contribute:

• Provides regulatory advice and oversight for assigned projects, focused on non-clinical and clinical aspects of vaccine 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, for both pipeline and marketed vaccines.

• Responsible for the regulatory oversight of assigned vaccine clinical trials conducted in the region.

• Close collaboration with the RAV International Regions Head, Area Leads and LOCs to ensure alignment and regulatory strategy execution during file preparation, submission, review, approval and life cycle management.

• Identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.

• In collaboration with the regulatory teams at LOCs, monitor the development of any new or modified  regulatory requirements/guidelines which could impact vaccine regulatory activities (registration, life cycle maintenance, etc). Responsible for the communication and advice on business impact of the new regulation in the assigned region. Close alignment with Area Leads in order to ensure  specifics requirements/regulations are considered in due time in VBU projects.

• Ensures compliance with both internal Takeda processes and policies as well as regional regulatory requirements.

• Supports Area Lead/International Regions Head and LOCs 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.

• Passion for quality in all areas of responsibility

• Leads and directs the work of others as part of a matrix organization.

What you bring to Takeda:

• BS degree or equivalent in a scientific discipline, advance degree preferred;

• Strong oral and written communication skills in English;

• Ability to work well with cross-functional teams;

• Independent and proactive in identification of regulatory issues and offering creative solutions;

• Ability to understand and interpret scientific issues in relation to regulatory requirements and strategy;

• Experience in lifecycle maintenance activities for vaccines will be considered an advantage;

• Desirable fluency in Spanish;

• Strong negotiation skills, integrity, flexibility, and adaptability.

**A Takeda está comprometida a promover uma cultura inclusiva, valorizando a diversidade (exemplo: pessoas com deficiência, religião, etnia, gênero, gerações e LGBTI+). Todas as nossas vagas seguem esse compromisso**

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