Regulatory Affairs Director

hace 3 días


Barcelona, Barcelona, España Sandoz A tiempo completo
Job Summary:
As Regulatory Affairs Associate Director, you will play a pivotal role in driving and delivering high-quality documentation to support successful submissions, ensuring timely and accurate reporting of regulatory activities, and coordinating the preparation and execution of regulatory documents.

Key Responsibilities:
• Lead, coach, and mentor associates within Regulatory API (RAPI) to achieve high-quality documentation and successful submissions.
• Ensure sufficient training and development opportunities to maximize regulatory competence.
• Take responsibility for financial targets and cost center management, ensuring timely and accurate reporting of regulatory activities.
• Perform and/or support analyzing group performance and making recommendations for improvement.
• Coordinate the preparation and execution of regulatory documents, ensuring compliance with current global regulatory standards.

Requirements:
• PhD (natural science) with at least 3 years of post-doctoral/industrial experience or Master/BSc (natural science) with at least 3 years of work-related experience, including people management experience.
• Leadership experience within regulatory affairs function.
• Broad knowledge of regulatory guidelines and software tools.
• Good communication, presentation, and documentation skills.
• Fluent oral and written English and Spanish.

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