Regulatory Affairs Manager

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