Nonclinical Regulatory Writing Manager
Company: VirtualVocations
Location: San Diego
Posted on: February 4, 2025
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Job Description:
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
Keywords: VirtualVocations, Indio , Nonclinical Regulatory Writing Manager, Advertising , San Diego, California
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