As a Regulatory Affairs Specialist, you will play a key role in compiling, reviewing, and submitting regulatory documentation to health authorities such as the EMA and FDA. You’ll work cross-functionally with R&D, Quality, and Clinical teams to ensure compliance throughout the product lifecycle—from early development to post-marketing support. Your responsibilities will include preparing regulatory submissions (CTAs, INDs, MAAs, NDAs), responding to authority queries, maintaining product registrations, and monitoring regulatory changes that may impact the organization. You will also contribute to regulatory strategy development and support audits and inspections by ensuring that documentation is current, accurate, and audit-ready.