Regulatory Strategy Manager

Role: Regulatory Affairs Specialist supporting neuropharmaceutical development programs, focusing on strategy execution and submission preparation. Responsibilities: develop, review, and file INDs, CTAs, DSURs, annual reports, and amendments; provide regulatory expertise on cross-functional teams; develop global regulatory strategies for CMC, nonclinical, and clinical activities; review clinical documentation, including protocols and consent forms; conduct regulatory research and communicate emerging regulations; maintain SOPs and ensure compliance with regulations. Requirements: BS/BA in Life/Health Sciences with 6+ years industry experience, including 3+ years in regulatory affairs at a research-based pharma, with FDA and ICH knowledge; or Master’s degree with 4+ years, or PharmD/PhD with 2+ years. Skills: strong project management, regulatory research, communication, and leadership abilities; proficient in US regulations and ICH guidelines. High-Value: experience with drug development, IND/CTA submissions, global regulatory strategy, and cross-functional collaboration. WorkSetup: not specified.