Junior Regulatory Affairs Associate with German Language skills

We are recruiting for a Junior Regulatory Affairs Associate to join our Clinical Trial Regulatory Services EU Consulting team in Poland! This is the perfect opportunity for a graduate with a science related degree who is keen to start their career in Clinical Trials/Regulatory!

German Language skills are essential for this role!

With sufficient training and support you will be responsible for:

• 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 Poland and other EU countries

• 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.

QualificationsThe 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

• Ability to work with a multinational team, focusing on multiple issues under tight timelines.

• Good Computer skills