Director, Regulatory Affairs, Ex-US

Role: Director of Regulatory Affairs (ex-US) supporting global development, focusing on European and international regions for Larimar's rare disease treatments. Primary objectives include defining and executing global regulatory strategies, managing submissions, and ensuring compliance to facilitate product development and approvals. Responsibilities involve leading regulatory submissions to international agencies, advising project teams on regulatory pathways, assessing global regulatory intelligence, and developing internal procedures. The role reports to the Senior Director of Regulatory Affairs and collaborates with Commercial, Medical, Legal, and Compliance teams. Qualifications: 5-8 years in pharmaceutical regulatory affairs, experience with EMA, MHRA, and global agencies, understanding of GxP and Quality principles, and strong document authoring skills for global submissions. Preferred skills include familiarity with rare disease product approvals and global health authority interactions. The position requires a proactive, detail-oriented mindset with excellent communication and project management skills. High-value specifics: focus on rare diseases, international regulatory submissions, global health authorities, and cross-functional collaboration. Work setup details and travel expectations are not specified.