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) for new registration applications and variation packages and renewals mainly in EU and US markets. Writing and compilation of product-specific CMC documentation (mainly Module 3 and relevant Module 2 sections) to support lifecycle activities. RA CMC change control evaluation/management, when necessary. Successful client management of regulatory affairs. Responsible for meeting deadlines, ensuring first time quality and maintaining customer satisfaction. Requirements: +1 year of experience in CMC in Regulatory Affairs in the Pharmaceutical Industry and/or Consultancy is required. Previous experience in regularoty affairs - CMC post-approval CMC changes and variations is highly desirable. 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. Adaptable 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. A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship. A highly & dynamic working environment with employees from more than 15 nationalities. Our people and their well-being are our priority: Physical, psychological and emotional well-being programme. Internal activities & RSC Activities Equal Opportunity Employer

📌 Regulatory Affairs Officer Cmc (España)
🏢 Asphalion
📍 España