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Job Details

Regulatory Affairs Consultant with German (Warsaw or Bucharest)

Company: PAREXEL
Location: Warsaw, Masovian Voivodeship,Poland
Reference: 49479BR
Closing Date: 21 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The role can be based in Warsaw or Bucharest (Romania)As part of a multi-national project team, you will help to coordinate the compilation, review and submission of regulatory agency applications for local projects in compliance with regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the team for the development of optimized clinical trial submission strategies. ...

Requirements:

The role can be based in Warsaw or Bucharest (Romania)

As part of a multi-national project team, you will help to coordinate the compilation, review and submission of regulatory agency applications for local projects in compliance with regulatory requirements as well as internal and client standard operating procedures (SOPs). Your knowledge of clinical trial regulations will enable you to support the team for the development of optimized clinical trial submission strategies.

Key accountabilities:

• Preparing/supervising of submission of documents (Initial packages, substantial amendments and other notifications) to the German, Austrian and Swiss CA
• Filling out initial application forms
• Quality check of submission packages
• Preparing label designs for the investigational medicinal products.
• Monitoring changes on the ongoing basis in EU legislation.
• Advising on EU guidelines, EU requirements.
• Acting in compliance with EU's pharmaceutical law, ICH-GCP, EU directives and in line with local and global procedures.

Qualifications

Ideal candidate will possess:

• Minimum Work Experience: initial years’ experience in an industry-related environment
• Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
• Language Skills: fluent vocal and written German, English and local language.
• Results Orientation
• Interpersonal Communication
• Teamwork & Collaboration
• Solving Business Problems
• Good computer skills

Ideal candidate will possess:

• Minimum Work Experience: initial years’ experience in an industry-related environment
• Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
• Language Skills: fluent vocal and written German, English and local language.
• Results Orientation
• Interpersonal Communication
• Teamwork & Collaboration
• Solving Business Problems
• Good computer skills

Apply for this job: Regulatory Affairs Consultant with German (Warsaw or Bucharest)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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