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Job Details

Regulatory Affairs Consultant (Clinical Trials)

Company: PAREXEL
Location: Prague
Reference: 39281BR
Closing Date: 30 Nov 17
Type: Full Time
Salary (£): Competitive

Job Summary:

PAREXEL Czech Republic is seeking an experienced Regulatory Affairs Consultant (Clinical Trials) to join their growing team in Prague!


You will act as a Regulatory Project Lead on assigned clinical research projects. As part of a multi-national project team, you will take the lead to coordinate the compilation, review and submission of regulatory agency applications for international clinical trials in compliance with international regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Scope of responsibilities:

• To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities
• To act as local regulatory contact and regulatory lead for assigned studies
• Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.
• Working under the general direction of the CTRS Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time
• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs
• Preparation and review of drug labels to ensure compliance with GMP Annex 13 and national requirements
• May prepare and/ or deliver presentation with the support of senior colleagues
• Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope.

Ideal candidate will possess:

• Education: Minimum of a Bachelor’s Degree in a Scientific Discipline, Advanced Degree Preferred.
• Minimum Work Experience: Several years’ experience in an industry-related environment (CRO or Pharma companies)
• Language Skills: Czech, fluent vocal and written English, additional language would be a plus.
• Excellent computer skills (MS Office)
• Excellent Communication Skills
• Teamwork & Collaboration
• Solving Business Problems

Apply for this job: Regulatory Affairs Consultant (Clinical Trials)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site

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