Associate Director, Regulatory Affairs Vaccines International Region

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Job Description

About the role:

The Regulatory Affairs, Associate Director ensures the organization gains regulatory approval for new products and product amendments, while maintaining the currency of product licenses and permits. This role helps Takeda navigate and comply with legislation and regulations, supporting the company's mission to bring better health to people and a brighter future to the world.

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

Skills and qualifications:

• BS degree or equivalent in a scientific discipline, advance degree preferred.
• A minimum of 8 years of pharmaceutical industry experience in regulatory affairs, preferably in working with Emerging Markets/APAC countries.
• Strong knowledge of vaccines and/or biologics development. Regulatory experience in vaccines is essential. Experience is lifecycle maintenance activities for vaccines is a plus.
• Understands and interprets scientific issues across projects as the issues relate to regulatory requirements and strategy.
• Proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies as applicable.
• Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity, flexibility and adaptability.
• Exceptionally strong in working and communicating well with others including global, regional and local teams as well as cross-functional teams.
• Accountable and team player.
• Fluency in English is a must.

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