Senior Regulatory Affairs Manager

Job Summary

To support regulatory compliance efforts, the contract Senior Regulatory Affairs Manager will manage the planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities while working remotely.

Key responsibilities

• Manage the submission of regulatory documents and serve as a subject matter expert on cross-functional teams
• Conduct regulatory research and identify potential compliance risks while recommending solutions
• Establish effective working relationships with Clinical, Clinical Operations, and CRO counterparts to ensure alignment on regulatory strategies

Required qualifications

• Bachelor's degree in a relevant field or equivalent experience
• Minimum of 5 years of direct regulatory affairs experience in the pharmaceutical or biotechnology industry
• Strong working knowledge of US FDA pharmaceutical regulations and guidance
• Proven track record of successful submissions, including IND and/or Clinical Trial Application filings
• Global clinical trials experience required; knowledge of EU EMA regulations is a plus