PAsphalion is growing and we are looking for ab Regulatory Affairs Consultant / Senior Consultant to join our CMC unit of consultants for the pharmaceutical industry /b! Someone who loves to take on new challenges, to work in an international environment and who wants to grow with us! /ppbr/ppbMain responsibilities: /b /pulliCMC writing of product specific dossiers (Mod. 2/Mod. 3), with special focus on biologics (including ATMPs and Biosimilars), for new registration applications and variation packages mainly in EU and US markets. /liliSupport in responses to deficiency letters, including coordination and preparation of responses. /liliCMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs. /liliRA CMC change control evaluation/management, when necessary. /liliRA CMC liaison with clinical and non-clinical teams, RA lifecycle management teams, technical/subject matter experts, QA, QC, production and supply, as per project needs. /liliIndependent CMC project management. /liliSuccessful client management of regulatory affairs. /liliEstablishment and improvement of CMC related processes and work instructions. /liliResponsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction. /liliPreparation and participation as a speaker in internal and external team related training sessions focused on CMC of biologics. /li /ulpbr/ppbRequirements: /b /pulli+5 years’ experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required. /liliPrevious experience predominantly with biological products /liliBackground in Biosciences or Health Sciences. /liliMicrosoft Office independent user level. /liliGood analytical, quality-oriented, and customer-focused skills. /liliHigh level of English (C1) /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 /ulpbr/ppbWhy working at Asphalion? /b /pp ️Permanent contract. /pp Flexible working schedule - Friday until 15.30h. /pp Remote Model b(You can work everywhere in Spain) /b /pp⚙️ Wide variety of projects, new challenges and experiences. /pp↗️ Training and personal development program. /pp English lessons. /p