Asphalion is growing and we are looking for a Scientific &
• Regulatory Affairs officer to join our team of CMC unit for the pharmaceutical industry! CMC writing of product specific dossiers (Mod. CMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs. Puede obtener más detalles sobre la naturaleza de esta vacante y lo que se espera de los solicitantes leyendo la información a continuación. RA CMC change control evaluation/management, when necessary. RA 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. Successful client management of regulatory affairs. Responsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction. 2 years experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required. ~ Microsoft Office independent user level. ~ Good analytical, quality-oriented, and customer-focused skills. ~ High level of English (C1) and Spanish ~ Good team player with good communication skills ~ Ability to handle multiple tasks/projects in a fast-paced environment ~ Permanent contract. Flexible working schedule - Friday until 15.30h. Homeoffice &
• Hybrid or Remote Model (You can be located anywhere in Spain!) Wide variety of projects, new challenges and experiences. Training and personal development program. English lessons. A professional, inclusive and high-performance work environment to develop your skills and grow your career. xbhjioe A great company culture built around Passion, Flexibility, Commitment, Quality &
• Companionship. Internal activities &
• RSC Activities
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