The CompanyFresenius Kabi is a leading global health care company that offers life-saving medical devices and medicinal products. At Fresenius Kabi we are dedicated to excellence with no compromise on quality, teamwork through respectful collaboration, serving patients beyond expectations, innovating healthcare by learning with our customers and partners, and acting today for a better tomorrow while being mindful of future needs and resources, all grounded in over 100 years of heritage. One of our business units is specialized in the development, manufacturing, and commercialization of high-quality generic medicines. Our mission is to make essential healthcare more affordable and accessible to patients worldwide.The RoleWe are looking for a motivated and detail-oriented CMC expert with experience in the pharmaceutical sector to join our growing team and contribute to the development of our generic’s portfolio. In this role, you will be responsible for preparing and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions, ensuring compliance with global regulatory requirements. The ideal candidate will possess strong communication skills, attention to detail, and a passion for quality.Key Responsibilities Prepare and review CMC documents for regulatory submissions of drug products (NDAs, variations, etc.), ensuring accuracy and complianceCollaborate with cross-functional teams (R&D, regulatory affairs, manufacturing sites, quality assurance, etc.) to gather and summarize technical dataEnsure all CMC documentation meets regulatory guidelines and company standardsCommunicate effectively with internal teams and external stakeholdersAdvise on strategy in the development and drive in the implementation of CMC strategiesContribute to continuous process improvements in CMC documentationKey RequirementsMinimum 2-3 years of experience in CMC writingUniversity degree in sciencesStrong understanding of CMC documentation requirements (EMA, ICH, etc.).Excellent written and verbal communication skillsDetail-oriented with a focus on accuracy and regulatory complianceMotivated, proactive, and capable of working independently and as part of a teamAbility to manage multiple projects and meet tight deadlines in a fast-paced environmentKnowledge of regulatory guidelines specific to generics and the submission process is a plusInterest in regulatory IT topicsWhat We OfferA dynamic, collaborative, and supportive work environment in vicinity to one of our production units and laboratoriesOpportunities to grow within a leading global pharmaceutical companyCompetitive salary and benefits packageExposure to exciting and impactful projectsHow to Apply If you are passionate about the pharmaceutical industry and ready to take the next step in your career and be part of our team, we would love to hear from you!Please send your application or ask more information to: recrutamento.portugal@fresenius-kabi.com