Closing Date: 03 Apr 17
Type: Full Time
Salary (£): On Application
PAREXEL Czech Republic is looking for Regulatory Professional to join their Prague team.
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.You will act as a Regulatory Project Lead on assigned clinical research projects. 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 (SOPs). Your knowledge of clinical trial regulations will enable you to support the sponsor for the development of optimized clinical trial submission strategies.Scope of responsibilities:• To prepare and coordinate of regulatory deliverables for assigned projects including close cooperation with regulatory authorities• To act as local regulatory contact and regulatory lead for assigned studies• Preparing, reviewing and compiling regulatory CTA applications, amendments, and end of trial notifications.• Working under the general direction of the CTRS Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs• Preparation and review of drug labels to ensure compliance with GMP Annex 13 and national requirements• May prepare and/ or deliver presentation with the support of senior colleagues• Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scopeIdeal candidate will possess:• Education: Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.• Minimum Work Experience: Several years' experience in an industry-related environment (CRO or Pharma companies)• Language Skills: Czech, at least fluent vocal and written English, additional language would be a plus.• Results Orientation• Excellent Communication Skills• Teamwork & Collaboration• Solving Business Problems
101-105 Oxford Road
|Tel:||+44 1895 238000|
|Fax:||+44 1895 238494|
|Website:||Visit Our Web Site|
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