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Senior Regulatory Strategist

Company: VirtualVocations
Location: Fullerton
Posted on: April 4, 2025

Job Description:

A company is looking for a Senior Regulatory Strategist to provide expert consultation on regulatory requirements for clinical trials and submissions.
Key Responsibilities

Provide expert consultation and advice on regulatory agency interactions and communications
Support the preparation of regulatory submissions and manage project teams
Build and maintain strong relationships with clients and regulatory agencies

Required Qualifications

Bachelor's degree in a related field required; advanced scientific degree preferred
15 years of relevant experience, with at least 10 years in regulatory affairs within clinical research or pharmaceutical settings
Thorough knowledge of ICH guidelines and regulatory rules, along with medical terminology and clinical trials
Experience as an authorized regulatory representative with a proven track record in global submissions
In-depth knowledge of the CRO industry and its relationship with pharmaceutical/biotech companies

Keywords: VirtualVocations, San Diego , Senior Regulatory Strategist, Other , Fullerton, California

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