Regulatory Affairs Manager

Job Summary

Leading regulatory strategy, the full-time salaried Regulatory Affairs Manager will manage a team of professionals while providing expert guidance on clinical development programs and regulatory submissions in a remote work environment.

Key responsibilities

• Lead regulatory activities for clinical development programs and ensure regulatory deliverables meet quality and compliance standards
• Provide expert regulatory guidance on clinical trial applications, submissions, and amendments while overseeing the preparation and submission of regulatory packages
• Manage and develop a team of up to 10 Regulatory Affairs employees, supporting their onboarding, training, and performance evaluations

Required qualifications

• Bachelor's degree in life sciences, pharmacy, healthcare, or a related field; advanced degree preferred
• 6-8+ years of relevant Regulatory Affairs experience within a CRO, pharmaceutical, or clinical research environment
• 1-3 years of management experience with a demonstrated ability to lead and mentor regulatory professionals
• Strong knowledge of global clinical research and regulatory requirements
• Proven ability to manage complex regulatory activities and submissions independently