Job Description

We are recruiting for a Regulatory Affairs Consultant to be based in our Prague Office, in the Czech Republic.

You will be required 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). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.

Responsibilities:
- Acting as a local regulatory contact representing various MAHs in Czech R. and/or Slovakia, especially covering all MAs related maintenance activities
- Acting as a local regulatory contact for clinical trials in the Czech Republic, Slovakia and Canada
- Preparation and quality control of core regulatory submission packages, preparation and quality control of local regulatory submission packages for submissions to RAs in the Czech Republic, Slovakia and Canada to ensure regulatory compliance, accuracy and completeness. Providing regulatory consultancy and support for establishing the submission strategy for clinical trial application, response management, amendments and other maintenance submissions.
- Interacting with Czech, Slovak and Canadian regulatory authorities, as required; liaise with internal and external partners on assigned projects, provide internal and external regulatory consultancy.
- Preparation, review and approval of labels.
- Acting as Global Regulatory Lead for clinical trial applications coordinating regulatory activities on international multi-center trials (design, plan and schedule activities and deliverables; interact with client and project team), support and development of submission plans and strategy to regulatory authorities, oversight and support for response management.
- Supporting SME team or acts as the SME to provide content to client proposals and
scoping.
- Mentoring and training junior team members/new joinersQualifications

Education:
Bachelor's Degree in a Scientific Discipline, Advanced Degree Preferred.

Minimum Work Experience:
Several years of work experience in the regulatory affairs in clinical trial and marketing authorization industry.

Skills:
• Fluency to communicate at a business standard verbally and in writing in English and local language
• Results Orientation
• Interpersonal Communication
• Teamwork & Collaboration
• Problem SolverWhy 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.