Regulatory Start-Up Manager

Job Summary

A company is looking for a Regulatory Start Up Manager II to join their Global SSU team.

Key Responsibilities

• Develop and manage the Regulatory & start-up submission project plan, ensuring compliance with timelines and deliverables
• Act as a liaison with the Sponsor for the approval and collection of core documents and submission packages
• Review submission components and provide feedback on regulatory acceptability, including master IP labels

Required Qualifications

• University degree in pharmacy, medicine, or related natural sciences is preferred
• Minimum of 7 years of professional experience, including 4 years as a Regulatory Start-up Manager at a local/country level
• At least 2 years of hands-on experience in global studies
• Experience working with multiple countries in global studies
• Working knowledge of FDA Guidance Documents, EU Directives, and ISO14155 regulations