Sr. Specialist, Regulatory Strategy

Role: Regulatory Affairs Specialist focused on preparing and managing regulatory submission documentation for new and existing biopharmaceutical products. Primary objectives include ensuring submissions meet regional and company standards, maintaining compliance, and supporting clinical trial and product license processes. Responsibilities encompass compiling regulatory packages (e.g., INDs, annual reports, safety reports), reviewing clinical regulatory documents, maintaining compliance logs, and coordinating revision procedures. The role may serve as the department’s contact for internal projects and tracking tools to support timelines and deliverables. Requirements: BS/BA with 4+ years, or Master’s with 2+ years, or JD/PharmD/PhD; strong knowledge of FDA and ICH guidelines; proficiency with regulatory tools and systems; excellent communication, project management, and detail orientation skills. Preferred qualifications include familiarity with US laws governing drug development and experience in regulatory document review. High-value specifics: US and ex-US regulatory knowledge, focus on clinical trial applications, IND maintenance, safety reporting, and regulatory compliance; cross-functional collaboration within the company’s clinical and development teams. Work setup details are not specified.