Descripción de la oferta
ppAsphalion is growing and we are looking for a Scientific Regulatory Affairs officer to join our team of CMC unit for the pharmaceutical industry! Someone who loves to take on new challenges, to work in an international environment and who wants to grow with us! /ppPor favor, asegúrese de leer completamente el resumen y los requisitos de esta oportunidad de empleo que se detallan a continuación. /ph3Main responsibilities /h3ulliCMC writing of product specific dossiers (Mod. 2/Mod. 3) for new registration applications and variation packages and renewals mainly in EU and US markets. /liliWriting and compilation of product-specific CMC documentation (mainly Module 3 and relevant Module 2 sections) to support lifecycle activities. /liliRA CMC change control evaluation/management, when necessary. /liliSuccessful client management of regulatory affairs. /liliResponsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction. /li /ulh3Requirements /h3ulli+1 year of experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required. /liliPrevious experience in regularoty affairs - CMC post-approval CMC changes and variations is highly desirable. /liliBackground in Biosciences or Health Sciences. /liliMicrosoft Office independent user level. /liliGood analytical, quality-oriented, and customer-focused skills. /liliHigh level of English (C1) and Spanish. /liliGood team player with good communication skills. /liliAbility to handle multiple tasks/projects in a fast-paced environment. /liliTruckloads of motivation, positivity, and enthusiasm. /li /ulh3Why working at Asphalion? /h3ulliPermanent contract. /liliVersátil working schedule - Friday until 15.30h. /liliHomeoffice Hybrid or Remote Model (You can be located anywhere in Spain!). /liliWide variety of projects, new challenges and experiences. /liliTraining and personal development program. /liliEnglish lessons. /liliA professional, inclusive and high-performance work environment to develop your skills and grow your career. A great company culture built around Passion, Flexibility, Commitment, Quality Companionship. /liliA highly dynamic working environment with employees from more than 15 nationalities. /liliInternal activities RSC Activities. /li /ulpOur people and their well-being are our priority: Physical, psychological and emotional well-being programme. /ppEqual Opportunity Employer /p /p #J-18808-Ljbffr
