Senior Specialist, Regulatory Affairs

Role: Senior Specialist, Regulatory Affairs, providing expertise in regulatory compliance strategies for biopharma products. Responsibilities: develop and review regulatory documents (CTDs), ensure compliance with US and international health authority requirements, assist in regulatory strategy development, and monitor evolving regulations. Qualifications: Bachelor's or Master’s in life sciences, with 7+ or 5+ years of regulatory compliance experience in pharmaceutical drug development; experience with US and international submissions preferred. Skills: strong knowledge of FDA, ICH guidelines, project management, document organization, and effective communication. High-Value: focus on immunotherapies, cell therapies, or biologics in development stages, with experience in regulatory submissions and compliance for marketed and pipeline products. Collaboration with scientific and regulatory teams. Work setup: full-time, predominantly desk-based; no specific travel requirements stated.