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