Regulatry Affairs Lead

Company Overview
オンコロジー領域に強みを持つ、外資製薬メーカー※プロジェクト数は業界TOP3

Job Description
The position is responsible for planning and execution of Japan regulatory strategy of the assigned products/projects by
➢ Providing strategic regulatory expertise for optimum market access of the products in Japan as a member of Japan project team and Global Regulatory
Strategy Team(GRST)
➢ Leading communication of the global regulatory strategy and its implication to Japan so that the context of regulatory input are properly understood by the
governance bodies in GMeds, iMeds and MedI for their quality decisions through communication with GRST/Global regulatory execution team (GRET).
➢ Preparing, updating, and implementing regulatory operational plans to deliver regulatory outcomes of the assigned products/projects.
➢ Managing quality regulatory deliverables of the assigned products/projects throughout the product’s lifecycle.
• JRL will also contribute to regulatory policy shaping within the TA by working closely with TA RAD and Regulatory Policy and Intelligence Department
• JRL will work flexibly within and across the Therapeutic Areas to provide broad operational and/or strategic support to ensure regulatory deliverables

Requirements
Education
• Bachelor’s Degree in Science or related discipline

Required Experience
• Relevant regulatory experience or experience elsewhere in Pharmaceutical industry
• Cross-functional project team experience
• Thorough knowledge of the drug development process
• Written and verbal communication skills
• Scientific knowledge sufficient to understand all aspects of regulatory issues

Preferred Experience
• Demonstrated experience in regulatory drug/device development, approval and launch.
• Proven leadership and program management experience.
• Ability to think strategically and critically evaluate risks to regulatory activities.
• Successful contribution to a major regulatory approval at a regional level.

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