Parexel International Corporation
We are recruiting for a Regulatory Affairs Associate to join our Clinical Trial Regulatory Services EU Consulting team in Spain.This is an ideal role for someone who would excel working in a fast-paced international team.
It is essential you are fluent in English, German and Spanish to apply for this role!
You will be responsible for:
• 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 (SOP's).
• You will manage CTA Submissions for Spain and Germany.
• 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
Ideal candidate will possess:
• Few years of experience in Regulatory Affairs and Clinical Research in Pharma or CRO.
• A degree in Life Sciences. Advanced degree will be an asset.
• Fluency in English and German is a must along with the local language.
• Experience in clinical study start-up.
• Ability to work with a multinational team, focusing on multiple issues under tight timelines.
• Good Computer skills
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