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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

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