Job Description

We are recruiting for a Regulatory Affairs Associate with Fluency in German language to join our Clinical Trial Regulatory Services EU Consulting teamin Italy.This is an ideal role for someone who would excel working in a fast-paced international team.

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 manageCTA Submissions for German speaking Countries Competent Authorities (Austria, Germany and Switzerland)
• 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, 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
Why 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.