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Global Regulatory Expert
5 days ago
Job Summary:
We are seeking a highly skilled Regulatory Affairs Manager to join our team in Copenhagen. The successful candidate will be responsible for providing regulatory services to support international multinational clinical trials in accordance with client requests.
The ideal candidate will have a strong understanding of Phase II–III and knowledge of Good Clinical Practice (GCP) regulations, ICH guidelines, and Clinical Trial Regulations.
Responsibilities:
- Prepare, review, and compile regulatory submissions.
- Liaise with regulatory authorities and provide expert advice on regulatory questions/issues.
- Maintain electronic files and regulatory trackers as required.
- Submit and support clinical trial applications to regulatory authorities within the EU.
- Develop regulatory documents for clinical trial submissions and scientific advice meetings.
- Act as a Project Lead for regulatory-only projects when required.
- Provide regulatory strategy and guidance to sponsors and internal teams to ensure compliance with regulations.
Requirements:
- Bachelor's Degree, preferably in life sciences or pharmacy, or equivalent experience.
- Minimum of 5 years of relevant experience in regulatory affairs within clinical research.
- Excellent written and verbal communication skills in English.
- Strong organizational skills and ability to manage multiple tasks effectively.
- Proficiency in Microsoft Office Suite (Word, Excel, MS Project).
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