Senior Regulatory Affairs Manager

A company is looking for a Senior Manager of Regulatory Affairs. Key Responsibilities Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities Collaborate with cross-functional teams to ensure alignment and support regulatory submissions Conduct regulatory research to inform business strategies and assess risks Required Qualifications, Training, and Education Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience Strong working knowledge of US FDA Pharmaceutical regulations and guidance Proven track record of successful submissions within a regulatory environment Knowledge of EU EMA and Rest Of The World Pharmaceutical regulations preferred Direct experience with IND/NDA filings is a plus

Created: 2026-03-05