Descripción de la oferta
Asphalion 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! Main responsibilities: CMC 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. Support in responses to deficiency letters, including coordination and preparation of responses. CMC support during drug development, including roadmaps, gap analysis and writing of CMC sections of IMPDs and INDs. 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. Requirements: ~+2 years experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required. ~ Previous experience with biological products ~ Background in Biosciences or Health Sciences. ~ 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 ~ Truckloads of motivation, positivity, and enthusiasm. Why working at Asphalion? ️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.
