Regulatory Affairs Manager - West Palm Beach Florida

Company: VirtualVocations
Location: West Palm Beach, Florida
Posted On: 02/06/2025

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 More...

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