【AstraZeneca】【R&D】Japan Regulatory Lead, BioPharma Therapy Area, Japan TA Regulatory Strategy & Policy Department, Regulatory Affairs Division

Description

• Japan Regulatory Lead (JRL) 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 Oncology R&D (ORD) and BioPharma R&D (BRD) 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 works flexibly within and across the Therapeutic Areas to provide broad operational and / or strategic support to ensure regulatory deliverables

Qualification (Experience & Skill etc.)

Experience】

Mandatory＞

Nice to have＞

License】

Mandatory＞

Bachelor’s Degree in Science or related discipline

Skill-set】

Mandatory＞

Nice to have＞

Language】

Mandatory＞

Japanese : Native level

English：Business English (Writing and verbal communication)

Nice to have＞

Business English (Achieve common understanding at the context level with customers)

Career Level】

Work Location】

Osaka or Tokyo

Date Posted

06-1月-2025

Closing Date