Nonclinical Regulatory Writing Manager - San Diego California

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

A company is looking for a Nonclinical Regulatory Writing and Submission Support, Sr. Manager.



Key Responsibilities

Develop and manage nonclinical regulatory documents for various drug products across multiple therapeutic areas
Lead cross-functional teams to ensure alignment on strategies and timelines for regulatory submissions
Implement innovative practices and automation to improve the regulatory writing framework and processes


Required Qualifications, Training, and Education

Ph.D. or M.Sc. in a scientific field with a minimum of 8 years of experience in nonclinical regulatory writing
Significant experience in authoring nonclinical summary sections for regulatory submissions
Experience in drug product development and regulated studies related to pharmacology, toxicology, or pharmacokinetics
Thorough understanding of global regulatory guidelines and submission content
Demonstrated ability to manage multiple programs and lead teams to meet regulatory deadlines More...

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