Regulatory Affairs Associate (M/F) - Lisboa, Lisbon
Client: Kelly Services
Location: Lisbon, Portugal
Job Category: Other
EU work permit required: Yes
Job Reference: e6ad7d0634d1
Job Views: 6
Posted: 23.06.2025
Expiry Date: 07.08.2025
Job Description:
* Update and maintain technical documentation for medicinal products in accordance with applicable regulatory requirements, including EU guidelines and other global frameworks.
* Collaborate with R&D, Quality Assurance, and Clinical Affairs teams to gather necessary documentation and data.
* Ensure all technical files are complete, current, and compliant with relevant laws and standards.
* Support the QARA department during audits and regulatory inspections.
* Provide regulatory advice to project teams regarding changes in product design, labeling, or manufacturing processes.
* Monitor regulatory developments in the medical device field and advise on necessary actions.
Job Requirements:
* Minimum 1 year of experience in Regulatory Affairs.
* Knowledge of local and European pharmaceutical legislation.
* Proficiency in English (B2 or higher); knowledge of Spanish is a plus.
* Bachelor’s or Master’s degree in Life Sciences.
Please apply by sending your CV through our portal.
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