Mgr Global Regulatory Scientist, Reg Aff

Role: Manager Global Regulatory Scientist in Regulatory Affairs, supporting registration and lifecycle management of pharmaceutical products. Responsibilities: draft and support IND, CTA, NDA, MAA submissions; ensure regulatory compliance; advise on submission strategies; coordinate with local operating companies (LOCs); lead interactions with health authorities; prepare meeting materials; manage responses to agency queries; support inspections, audits, and product complaints; contribute to regulatory process improvements; participate in global teams; research regulatory requirements and develop strategies. Requirements: Bachelor's degree in a scientific discipline; 4+ years in regulatory affairs within pharma/biotech; experience with global health authorities, FDA and ICH guidelines, and lifecycle management of clinical trials and marketing applications; knowledge of oncology and combination products is advantageous; strong project management, strategic thinking, and communication skills. HighValue: global regulatory submissions, health authority interactions, lifecycle management, oncology experience, combination products, cross-functional collaboration. WorkSetup: hybrid positions available in Belgium, the Netherlands, UK, or US; ~10% domestic, potential international travel.