Regulatory Affairs Manager
Company: VirtualVocations
Location: Gary
Posted on: February 4, 2025
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Job Description:
A company is looking for a Manager, Regulatory Affairs.
Key Responsibilities
Manage regional regulatory activities as part of the Global
Regulatory Team
Support the global regulatory lead in the formulation of regulatory
strategy and interactions with health authorities
Assist with the preparation, coordination, and monitoring of
routine US regulatory submissions and responses to health authority
information requests
Required Qualifications, Training, and Education
B.S. degree, preferably in a scientific discipline
2-4 years of experience in the biopharmaceutical or pharmaceutical
industry, with a minimum of 2 years focused in regulatory
affairs
Experience contributing to electronic regulatory submissions and
familiarity with regulatory templates
Knowledge of FDA and ICH regulations/guidance specific to clinical
research and product development
Ability to work in a diverse environment and adapt to changing
priorities
Keywords: VirtualVocations, Carol Stream , Regulatory Affairs Manager, Executive , Gary, Illinois
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