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Remote Regulatory Affairs Strategy Consultant

Company: VirtualVocations
Location: Fullerton
Posted on: November 17, 2022

Job Description:

A global biotech company is seeking a Remote Regulatory Affairs Strategy Consultant.

Core Responsibilities Include:
Providing strategic and operational input, guidance and oversight to global project teams
Developing and creating regulatory compliance strategies for multiple clinical development projects
Coordinating all aspects of the preparation, review and submission of regulatory documents
Must meet the following requirements for consideration:

Bachelor's degree in a relevant scientific discipline
10-15 years of regulatory affairs experience in the pharmaceutical industry
Understanding of global regulatory submissions
Relevant filing experience in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings
Strong written and oral communication skills and the ability to interact effectively with project teams
Ability to manage regulatory affairs activities and provide leadership in a hands-on fashion

Keywords: VirtualVocations, Fullerton , Remote Regulatory Affairs Strategy Consultant, Other , Fullerton, California

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