CSL
Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology
10,000+
💰 $111M Post-IPO Equity on 2004-02
Senior Regulatory Strategy Expert
October 31
CSL
Complex biologicals • vaccines • plasma and plasma derived therapeutics • biotechnology
10,000+
💰 $111M Post-IPO Equity on 2004-02
Description
• Senior Regulatory Strategy Expert is responsible for all regional regulatory strategic and operational tasks for a range of development products/projects in the assigned TAs in Japan. • This role reports to: Regulatory Strategy Group Manager, Regulatory Affairs, R&D Japan. • The Senior Regulatory Strategy Expert oversees the compilation of relevant high-quality documentation for submissions in Japan, including new drug applications, partial change applications, expedited regulatory applications like orphan drug designations etc., clinical trial notifications, according to agreed schedules while taking into account local specific requirements.
Requirements
• Bachelor’s degree in a Life Science. • Advanced degree in a Life Science (MSc, PhD, MD) or Business Administration (MBA) preferred. • At least 7 years of regulatory affairs and/or other R&D functions in pharmaceutical companies. • At least 5 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. • 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).
Benefits
• We encourage you to make your well-being a priority. • It’s important and so are you.
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