Especialista en CMC - Regulatory Affairs

ALTEN Spain , a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and skilled CMC Specialist . ALTEN Group Within 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN , composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors. Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too? This person will be involve in the technical drafting of Regulatory Affairs documents that help ensure the proper development of standards related to the pharmaceutical sector. Responsibilities: ⁠Manage and draft CMC regulatory documents. Manage various documentation for specification justification. Perform change control. Have experience in drafting and updating Module 2 and 3. Carry out documentation filing. Have a scope at the European Union and International level. Requirements: ⁠Intermediate-high level of English - minimum B2. Between 1 and 2 years of experience in CMC Documentation. Experience with Module 2 and 3 of the eCTD. Availability to work in a hybrid model - 50% on-site - 50% remote. Why Join Us? Possibility to work with cutting-edge technology in the Life Sciences industry. Collaborative and dynamic work environment. Possibility to join a top-leading company in the industry. Continuous trainings. Possibility to join different and interesting projects. If you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you

Location: barcelona-barcelona, ES

Posted Date: 2/5/2025