Senior Manager or Associate Director, Lifecycle RA

BeiGene

Full time Japan, Japan Top Executives

Posted:

February 20, 2026

Location:

Japan, Japan, Japan

Job Description

Job Description:
General Description: 
Local Representative for Regulatory Affairs, Local Compliance
Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase, with proactive input into commercial regulatory requirements during development.
Act as an internal consultant on pharmaceutical regulations, including the PMD Act.
Collect, analyze, and implement domestic pharmaceutical regulations; monitor and share regulatory trends (e.g., ICH, PIC/S, MHLW/PMDA).
Promote regulatory awareness through internal briefings and materials on PMDA/MHLW updates and guidelines.
Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.
Oversee business license management (e.g., MAH, manufacturer) and collaborate with GQP/GVP departments.
Package Insert (labeling) maintenance ...
                

Apply for this Job

Submit your application for the Senior Manager or Associate Director, Lifecycle RA position at BeiGene.

Apply Now Save for Later

Job Overview

Job Type: Full time

Location: Japan, Japan

Posted: February 20, 2026

Deadline: April 01, 2026