Director of Nonclinical Regulatory Writing - Fresno California

Company: VirtualVocations
Location: Fresno, California
Posted On: 02/05/2025

A company is looking for a Director, Nonclinical Regulatory Writing and Submission Support, Team Lead.



Key Responsibilities

Manage the nonclinical internal writing team and ensure high-quality deliverables across all programs
Lead the planning, tracking, and regulatory compliance of nonclinical technical and regulatory components
Develop and implement best practices and standard operating procedures to ensure operational excellence


Required Qualifications

Ph.D. in a scientific field with a minimum of 12 years of experience in nonclinical or scientific writing
A minimum of 3 years of managerial experience in the pharmaceutical industry
Significant experience in authoring nonclinical summary sections for regulatory submissions
Thorough understanding of global regulatory guidelines and submission content
Experience with regulatory submissions for new modalities is an advantage More...

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