CSL
Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology
10,000+
💰 $111M Post-IPO Equity on 2004-02
Regulatory Strategy Group Manager - Associate Director
October 31
CSL
Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology
10,000+
💰 $111M Post-IPO Equity on 2004-02
Description
• The Regulatory Strategy Group Manager is a key leadership position in Japan Regulatory Affairs (RA). • The Regulatory Strategy Group is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects across all Therapeutic Areas (TAs) in Japan. • The role reports to Head Regulatory Affairs, R&D Japan. • The manager is accountable and responsible for the group’s performance, leadership, and continuous growth.
Requirements
• Bachelor’s degree in a Life Science. • Advanced degree in a Life Science (MSc, PhD, MD) or Business Administration (MBA) preferred. • At least 15 years of regulatory affairs and/or other R&D functions in pharmaceutical companies. • At least 10 years of regulatory development experience for development products such as new drug application, partial change application, expedited regulatory application, clinical trial notification, PMDA consultation etc. • People leader’s experience preferred. • Japanese and global regulatory legislation knowledge. • Microsoft Office skills. • Regulatory specific systems skills (e.g. RIMS, FD application). • Fluent Japanese and English communication skills (both written and spoken). • Empathy with CSL values: Patient Focus, Innovation, Integrity, Collaboration, Superior Performance.
Benefits
• We encourage you to make your well-being a priority. • It’s important and so are you. • Learn more about how we care at CSL.
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