Regulatory Site Lead, Glostrup

Job description

Job Description We are seeking an experienced Regulatory Affairs leader to serve as the Regulatory Site Lead for the Glostrup manufacturing site. This Expert Level role provides on‑site regulatory leadership with a strong manufacturing focus, ensuring regulatory considerations are embedded early into site initiatives and day‑to‑day operations. This leader interacts closely with global and onsite regulatory colleagues. The Regulatory Site Lead is a key regulatory partner to site leadership and cross‑functional teams, supporting compliant and efficient manufacturing operations, inspection readiness, and supply continuity. This role acts as the primary regulatory interface for site changes, audits, and regulatory inquiries, translating regulatory requirements into clear, practical guidance at the site level. Key Responsibilities: Provide hands‑on regulatory leadership aligned with site manufacturing processes and GMP requirements. Proactively identify regulatory impacts of site changes (e.g., process, equipment, materials, suppliers) and ensure they are assessed early and managed effectively through appropriate regulatory pathways. Serve as the regulatory lead for health authority and...