Regulatory Manager / Senior Regulatory Manager

March 29

Precision Medicine Group

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Moving Science Closer to Health

1001 - 5000

💰 $35.2M Venture Round on 2021-03

Description

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities including CTA/IND, annual reports, routine amendments, etc. • Serve as representative of Global Regulatory Affairs at project team meetings • Keeps abreast and expands knowledge of laws, regulations and guidelines governing drug development and approval

Requirements

• Bachelor's degree, ideally in a scientific or healthcare discipline • 5 years Regulatory experience required for Manager level, 7 years for Senior Manager Regulatory level • Computer literacy (MS Office/Office 365) • Fluent in English • Have regulatory affairs experience working for a Clinical Research Organisation • Informed knowledge of drug development process and regulatory activities for at least one major region • Ability to understand clinical and pre-clinical study results • Availability for domestic and international travel including overnight stays

Benefits

• Competitive salary • Flexible working hours • Opportunities for professional development • Travel opportunities