Regulatory Affairs Manager

Job Summary

Supporting global regulatory activities for early- and late-stage development programs, the full-time remote Regulatory Affairs Manager will manage regulatory submissions, collaborate with cross-functional teams, and ensure compliance with health authority requirements.

Key Responsibilities

• Support preparation, review, and submission of regulatory filings including INDs/CTAs and amendments
• Assist in coordination and preparation of global health authority meeting documents
• Contribute to global regulatory strategy and ensure submissions meet health authority requirements and quality standards

Required Qualifications

• Bachelor's degree, preferably in a scientific discipline
• 6+ years of pharmaceutical industry experience, including 4+ years in Regulatory Affairs
• Strong knowledge of U.S. and international regulatory requirements for drug development
• Experience supporting initial INDs/CTAs and initial marketing application activities is highly desirable