Lonza
Life Sciences
RegulatoryAffairsSpecialist
“Regulatory Affairs Specialist at Lonza. Skills: Regulatory Affairs, Regulatory submissions, Compliance activities. Lead and supervise the Tokyo Regulatory Affairs team. Coordinate regulatory submissions and compliance activities”
What You'll Achieve.
Bring innovative life science solutions to market in compliance with Japanese regulations
Industry & Context.
What They're Looking For.
Must Have
Advanced experience in Regulatory Affairs, Knowledge of Japanese regulatory requirements, Ability to thrive in a fast‑changing environment and proactively drive change across the organization, Strategic and hands-on mindset, Native Japanese and business-level English
Nice to Have
CDMO regulatory experience
What You'll Do.
Lead and supervise the Tokyo Regulatory Affairs team
Coordinate regulatory submissions and compliance activities
Act as a regulatory contact point for customers and authorities
Provide regulatory intelligence for Japan
Partner with internal business teams on regulatory impact
Support team performance and continuous improvement
Contribute to cross-site regulatory projects
How You'll Work.
Team & Collaboration
Partner closely with internal and external stakeholders; Partner with internal business teams on regulatory impact
Communication Scope
communication skills
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