Principal Regulatory Writer

Job Summary

A company is looking for a Principal Regulatory Writer with a NonClinical focus.

Key Responsibilities

• Lead the development of strategies and prepare regulatory documents in collaboration with clients and internal teams
• Author high-quality study-level and submission-level documents while managing project teams and budgets
• Provide mentorship to junior staff and ensure compliance with standard operating procedures and training requirements

Required Qualifications

• Bachelor's degree; MS or PhD preferred
• 10+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD
• Understanding of regulatory authority guidelines and experience in developing submission-level documents
• Experience in leading internal project teams and anticipating writing practice conventions' effects on final products