Regulatory Affairs Contractor Must be based in Poland or Spain! Opportunity to contribute to high-impact regulatory submissions in a dynamic, collaborative setting (6 month full-time contract). Key Responsibilities: * Support EU regulatory development strategies and execution for key pipeline programs. * Prepare, submit, and manage CTAs (applications via CTIS) and contribute to the preparation of initial MAAs * Assist in the development and submission of Paediatric Investigational Plans (PIPs) and full waiver requests. * Prepare for and participate in EMA and national Health Authority meetings, including Scientific Advice and regulatory briefings. * Monitor and interpret evolving EU regulatory guidelines relevant to ongoing studies and development plans. Key Requirements: * 7+ years of Regulatory Affairs experience in the pharmaceutical or biotech industry. * Hands-on experience with EU CTAs via CTIS, including submitting initial applications and maintenance. * Prior experience with MAA submissions, scientific advice and PIPs * EU regulatory experience essential, US desirable * Experience working in or supporting small biotech, pharma, or CRO environments and exposure to global team environments