Principal Regulatory Writer
VirtualVocationsSan Bernardino, California, United Statesjob_description.job_card.variable_days_ago
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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
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Principal Regulatory • San Bernardino, California, United States
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