Regulatory Submission Specialist (EN) Belgium Brussel (BE) • Oxford Global Resources

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For one of our clients, a global health care company, we are looking for an experienced Regulatory Submission Specialist.

Job Description

The Submission Specialist supports regulatory activities at study start up, focusing on submission to Ethics Committees (EC) and Competent Authorities (CA).

Responsibilities

• Prepare documents for Ethics Committee/Competent Authority (EC/CA) submission.
• Initiate translation of documents as applicable; review and adapt translations as appropriate.
• Prepare Country/Site Specific Patient Informed Consent form according to Regulatory and EC requirements and obtain internal approval where applicable.
• Interpret clinical study protocols in order to support EC/CA submission
• Act as the point of contact for EC /CA
• Support approval process
• Support budget adoption to country and site requirements.
• Prepare submission to any other authority when applicable.
• Maintain local regulatory documents on paper or electronically as applicable and ensure upload to appropriate system.
• Assist with collection of site essential documents.
• Attend project related meetings.
• Comply with all regulations in force, Company policies, operating procedures, processes, and task assignments.
• Inform manager if timelines appear to be at risk so that appropriate actions may be taken.
• Serves as a liaison to clinical teams and site personnel for administrative questions

Requirements

• Bachelor's or Master's degree, previous experience with EC/CA submissions
• Fluent in English, any other language is an asset
• Ability to use discretion and handle sensitive/confidential information.
• Ability to work independently when necessary.
• Ability to exchange straightforward information, ask questions, and check for understanding.
• Ability to multitask, prioritize and meet deadlines.

Contract Information

• Full-time position
• Office-based position in a dynamic, international environment
• Permanent contract

JOb number : 26637