Junior Regulatory Affairs Associate with German Language skills

Budapest, Hungary
12 Feb 2021
03 Mar 2021
Clinical Research
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

We are recruiting for a Junior Regulatory Affairs Associate to join our Clinical Trial Regulatory Services EU Consulting team! You can be based in Spain, Poland or Hungary! 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 manageCTA 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.

The 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 skillsWhy Work at Parexel

There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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