PRegulatory Affairs Contractor /ppMust be based in Poland or Spain! /ppbr/ppOpportunity to contribute to high-impact regulatory submissions in a dynamic, collaborative setting (6 month full-time contract). /ppbr/ppbKey Responsibilities: /b /ppbr/pulliSupport EU regulatory development strategies and execution for key pipeline programs. /liliPrepare, submit, and manage bCTAs /b(applications via bCTIS) /band contribute to the preparation of binitial MAAs /b /liliAssist in the development and submission of bPaediatric Investigational Plans (PIPs) /b and full waiver requests. /liliPrepare for and participate in bEMA and national Health Authority meetings /b, including Scientific Advice and regulatory briefings. /liliMonitor and interpret evolving EU regulatory guidelines relevant to ongoing studies and development plans. /li /ulpbr/ppbKey Requirements: /b /ppbr/pullib7+ years /b of Regulatory Affairs experience in the pharmaceutical or biotech industry. /liliHands-on experience with bEU CTAs /b via bCTIS, /bincluding submitting initial applications and maintenance. /liliPrior experience withb MAA submissions, scientific advice and PIPs /b /lilibEU regulatory experience essential, US desirable /b /liliExperience working in or supporting bsmall biotech, pharma, or CRO environments /band exposure to bglobal team environments /b /li /ul