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 manageCTAs(applications viaCTIS)and contribute to the preparation ofinitial MAAsAssist in the development and submission ofPaediatric Investigational Plans (PIPs)and full waiver requests.Prepare for and participate inEMA 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+ yearsof Regulatory Affairs experience in the pharmaceutical or biotech industry.Hands-on experience withEU CTAsviaCTIS,including submitting initial applications and maintenance.Prior experience withMAA submissions, scientific advice and PIPsEU regulatory experience essential, US desirableExperience working in or supportingsmall biotech, pharma, or CRO environmentsand exposure toglobal team environments
El anuncio original lo puedes encontrar en Kit Empleo:
Https:
//www.Kitempleo.Es/empleo/218580048/g-092-regulatory-contractor-gijon/?utm_source=html
#J-18808-Ljbffr