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 has become a leader in both outsourced Engineering and IT Enterprise Services.
With 54,000 employees (88% engineers), we carry out complex and highly technical projects throughout the value chain for 6,500 clients, including the most prestigious companies in 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 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 a difference too?
Responsibilities:
1. Manage and draft CMC regulatory documents.
2. Manage various documentation for specification justification.
3. Perform change control.
4. Draft and update 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 join different and interesting projects.
If you want to embrace a new and challenging opportunity and are excited about the prospect of contributing to our team, we want to hear from you.#J-18808-Ljbffr