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Senior Regulatory Affairs Associate with French (Clinical Regulatory)
Parexel International Corporation
Romania - Any Region - Home Based
Parexel International Romania is currently looking for an experienced, French-speaking Senior Regulatory Affairs Associate.
In this position you will be responsible for:
• Compiling and submitting to HA clinical trial applications in compliance with regulatory requirements as well as internal guidelines
• Liaising with EU regulatory authorities (mainly France and Belgium) for the initial authorization as well as maintenance of clinical trials authorization
• Conducting reviews of key technical study documents to ensure completeness, scientific accuracy, regulatory compliance, consistency with other key documents, and ease of review
• Providing regulatory advice to project teams of assigned projects
• Escalating, informing and resolving any issues that may impact submission Qualifications
The ideal candidate will possess:
• University degree in Life Sciences.
• Minimum 3 years of experience in Regulatory Affairs (Clinical Trials) within Pharma or CRO.
• Understanding and proven execution of CTA process.
• Fluency in English and French is a must.
• Ability to work with a multinational team, focusing on multiple issues under tight timelines.
• Good computer skills.
Job posted: 2021-12-15