Regulatory Affairs Specialist

Regulatory Affairs Specialist is responsible for all regulatory activities associated with assigned medicines within their geographical and/or brand area of responsibility, including compilation and submission of new submissions and post-approval variations, managing regulatory commitments, coordinating regulatory strategies across the EMEA region, and ensuring compliance with local regulatory and quality requirements. The role involves submitting regulatory applications (MRP, DCP, Workshare), developing partnerships with R&D, marketing, and local regulatory teams, and staying abreast of regulatory developments to support timely approvals.