Regulatory Affairs Associate (M/F) - Lisboa Lisboa

Regulatory Affairs Associate (M/F) - Lisboa
Lisboa
Lisboa, Lisboa, Portugal

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United States

Regulatory Affairs Associate (M/F) - Lisboa

Lisboa

EUR 30, 000 - 40, 000

Client:

Client: Kelly Services

Location: Lisbon, Portugal

Job Category: Other

EU work permit required: Yes

Job Reference: e6ad7d0634d1

Job Views: 21

Posted: 09. 02. 2025

Expiry Date: 26. 03. 2025

Job Description:

As a Regulatory Affairs officer, your responsibilities will include:

• Update and maintain technical documentation for medicinal products in accordance with applicable regulatory requirements, including but not limited to the EU guidelines, and other global regulatory frameworks.
• Collaborate with
  - functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather necessary documentation and data.
• Ensure all technical files are complete, current, and in compliance with relevant laws and standards.
• Support the quality & regulatory department (QARA), in audits and regulatory inspections.
• Provide regulatory advice and guidance to project teams on regulatory requirements, especially related to changes in product design, labeling, or manufacturing processes.
• Monitor regulatory developments within the medical device field and advise on impact and necessary actions.

Job Requirements:

• Minimum experience 1 year in Regulatory Affairs;
• Knowledge regarding local and European pharmaceutical legislation;
• Proficiency in English (B2 or higher) and knowledge of Spanish will be valued;
• Bachelor or Master’s degree in Life Sciences industry.

Please apply by sending your CV through our portal.