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Job Details

Senior Regulatory Affairs Associate

Company: PAREXEL
Location: Berlin, Land Berlin,Germany
Reference: 41472BR
Closing Date: 21 Feb 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

Key Accountabilities: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). ...

Requirements:

Key Accountabilities:

  • 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).
  • You will coordinate and manage flow of information, track project progress, and identify and solve problems in a team-oriented environment.
  • You will be involved in critical reviews of key technical documents (e.g. clinical trial protocols and reports, study drug labels, and other clinical trial related technical documentation) to ensure regulatory compliance for clinical trial applications, consistency with other key documents and ease of review.
  • You will interface with the project team, the sponsor and the regulatory authorities on regulatory and technical matters, as appropriate.
  • You are expected to acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and disciplines areas relevant to assigned projects and advise clients and internal staff accordingly.
  • Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.
Qualifications
  • You have a Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
  • Fluency in English is a must (any additional European languages are a plus).
  • Relevant experience in an industry-related environment.
  • Previous experience in Regulatory Affairs work or related work and Clinical Research environment and project management skills.
  • You are a team player with a high degree of client orientation along with good organizational skills and the ability to prioritize and complete complex tasks effectively in an accurate and timely manner.
  • Excellent communication skills.

Apply for this job: Senior Regulatory Affairs Associate

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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