Regulatory Affairs ContractorMust 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