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Job Details

Regulatory Submissions Coordinator / Senior Regulatory Submissions Coo

Company: Just Pharma
Location:
Reference: DBRSC
Closing Date: 05 Jan 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

A global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Who continue a steady growth and are looking to add to their team!

Requirements:

POSITION SUMMARY

Their European activities are growing rapidly, and they are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success.

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Ours is a culture of expertise, and we empower our teams to employ their unique talents and experience to take an assertive approach to research, problem solving, and ultimately supporting our partners. My clients employees embody their values and their approach to serving our clients. They work hard, understand our high expectations, and rise to the challenge. In return they are rewarded with interesting projects, career advancement, and recognition and exposure to our international footprint. These are just a few reasons talented individuals join my client's team.

DUTIES AND MAIN RESPONSIBILITIES
• Prepare, review, and file initial clinical trial applications to regulatory authorities and Ethics committees in Germany, Austria and Switzerland;
• Prepare and submit responses to queries and amendments to clinical trial applications;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements;
• Track submissions and ensure timely filing of documents;
• Collection of essential documents and preparation essential documents packages for drug release.

QUALIFICATIONS/REQUIREMENTS
• Bachelor's degree in life sciences;
• Excellent organization and communication skills;
• Knowledge of Microsoft® Office;
• Hands-on experience preparing, reviewing, and submitting regulatory documentation;
• At least one year of work experience as a Regulatory Submissions Coordinator;
• Minimum 4 years’ experience for the Senior Regulatory Submissions Coordinator position;
• Fluency in English and German language.

 

 

 

 

danielle@justpharma.co.uk 00441707817621 

Apply for this job: Regulatory Submissions Coordinator / Senior Regulatory Submissions Coo

Contact Information:

Address:  Head Office
2nd Floor Albany Chambers, Bridge Road East, Welwyn Garden City, Hertfordshire
AL7 1HL
England
Tel:  0044 1707 830300
Website:  Visit Our Web Site

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