Manager, Regulatory Affairs

Role: Regulatory Affairs Manager overseeing FDA submissions for drug applications. Responsibilities: review and approve INDs, NDAs, ANDAs, supplements, and annual reports; provide feedback on technical documentation; recommend regulatory reporting mechanisms; ensure compliance with FDA regulations; prepare and finalize submissions; track regulatory commitments; review internal documentation such as change controls and batch records; maintain current regulatory knowledge. Requirements: Bachelor's degree (science preferred), 4-7 years of experience in regulatory affairs, proficiency in English, strong documentation and communication skills, ability to interpret technical documents, problem-solving skills, and physical ability for site work. HighValue: experience with FDA submissions (IND, NDA, ANDA), regulation review, technical documentation, change control processes, regulatory compliance, and cross-department collaboration. WorkSetup: 2-3 days/week in Washington, DC office.