Senior Specialist, Regulatory Strategy

Role: Regulatory Affairs Specialist focused on preparing and coordinating regulatory submissions for neuropharmaceutical products. Main objectives include ensuring compliance with regional and local registration requirements, overseeing document compilation, maintaining tracking systems, and supporting regulatory strategy for clinical trials and product licenses. Responsibilities encompass preparing submissions such as INDs, annual reports, safety reports; reviewing clinical regulatory documents; maintaining compliance logs; coordinating review workflows; and acting as a departmental contact for project activities. Requirements include BS/BA with 4+ years, or Master’s with 2+ years, or JD/PharmD/PhD without experience; strong understanding of FDA regulations, ICH guidelines, and drug development laws; proficiency in regulatory tools and processes; excellent communication, problem-solving, project management, and attention to detail. Preferred qualifications involve experience in neuropharma, clinical trial regulatory processes, and familiarity with US and ex-US regulatory environments. The role supports a pipeline of neurological, psychiatric, endocrine, and immunological therapies, with a focus on clinical phases and product lifecycle management. Work setup details are not specified, but the position involves cross-functional collaboration within a biopharma setting.