Job Description

We are recruiting for a Regulatory Affairs Consultant in Ukraine!

If you have the following experience we would love to hear from you:

- Strong skills in research planning and conduct within multinational environment, scientific information
search, data analysis and presentation. Significant experience in preparation, review and compilation of
regulatory applications, review and analysis of key clinical documents, QC conduct of all the essential
clinical trials documents, label development. Thorough knowledge of ICH/GCP guidelines and national
legislation related to the clinical trials conduct. Project level/asset level regulatory support of multi-regional
clinical studies.
- Regulatory leadership of small-scale, medium and large multi-regional studies;
- Regulatory support and consultation to global and local study teams and sponsor, design and
completion of regulatory deliverable for assigned projects, track of project progress, identification and
solving problems in a team-oriented environment; - Review of key technical documents aiming to ensure completeness, scientific accuracy, regulatory
compliance, consistency with other key documents and ease of review;
- Global and local Label text development coordination and support;
- Label development project leadership support;
- Participation in Regulatory Affairs meetings and training initiatives, project team meetings
- Maintain effective working relationship with other departments and regulatory agencies.
- Junior team members mentoring.Qualifications

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.