ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail‐oriented Regulatory Affairs CMC Specialist, with strong experience in preparing, reviewing, and submitting eCTD Module 3 (Quality/CMC) documentation for Latin American markets, ensuring regulatory compliance, liaising with Health Authorities, and supporting responses to regulatory queries within regulated pharmaceutical and life sciences environments.
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 role as a Regulatory Affairs CMC Specialist requires a strong understanding of pharmaceutical quality and CMC requirements, manufacturing and analytical processes, and the ability to work cross-functionally to prepare, review, and submit eCTD Module 3 (Quality/CMC) documentation within Latin American markets.
Key Responsibilities:
* Prepare, review, and maintain Module 3 (Quality / CMC) documentation of the eCTD for regulatory submissions
* Ensure CMC dossiers are aligned with applicable regulatory requirements and guidelines for Latin American markets
* Coordinate and manage regulatory submissions, variations, renewals, and responses to questions related to CMC documentation
* Act as the main point of contact with local and regional regulatory authorities, supporting regulatory interactions and clarification requests
* Work closely with cross-functional teams (Quality, Manufacturing, Analytical Development, Supply Chain, and R&D) to gather and verify CMC data
* Ensure consistency, accuracy, and traceability of quality-related data across regulatory submissions
* Monitor and assess regulatory changes and guidelines impacting CMC requirements in Latin American countries
* Maintain regulatory documentation and ensure timely updates in internal systems and submission tools
Qualifications:
* Degree in Engineering, Pharmacy, Life Sciences, or a related fiel
* Proven experience in Regulatory Affairs CMC, with direct involvement in Module 3 of the eCTD
* Solid knowledge of CMC requirements and regulatory frameworks in Latin American markets
* Experience submitting dossiers and interacting with Health Authorities in the LATAM region
* Fluent in English and Spanish is mandatory
* Ability to work effectively with cross-functional and international teams
Location: Lisbon (100% 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! Please submit your resume and cover letter detailing your relevant experience and qualifications.