Sr. Specialist, Regulatory Strategy

Role: Regulatory Affairs Specialist focusing on preparing and coordinating regulatory submissions for neuropharmaceutical products. Objectives: ensure compliance, timely submission, and alignment with regional and global regulatory standards to support product lifecycle management and clinical trial approvals. Responsibilities: compile and review regulatory documents (e.g., INDs, annual reports, safety updates), maintain submission tracking systems, coordinate review processes, and serve as departmental contact for internal projects. Qualifications: BS/BA with 4+ years (or advanced degrees with less experience), strong understanding of FDA and ICH regulations, proficient in regulatory systems and tools, excellent communication and project management skills. HighValue: focus on neurological, psychiatric, endocrine, and immunological therapies, with involvement in clinical trial and product registration activities, requiring knowledge of US and ex-US regulatory landscapes, and experience supporting IND submissions and compliance documentation.