Regulatory Affairs Associate
- Experience Level
- Experienced (non-manager)
PRA Health Sciences is a Clinical Research Organisation experiencing exceptional growth globally. The people we employ are key to this growth.
People don’t come to PRA to witness the future of clinical development, they come to shape it. With an average of more than 6 former employees returning to PRA each month we can confidently say that the grass is greener at PRA. Come join the movement and discover your passion, your purpose, your PRA.
This role offers the right candidate with the opportunity to join growing Regulatory Clinical Services Team. Regulatory Affairs Associate (RAA) coordinates preparation and submissions of clinical trials applications, substantial amendments in compliance with applicable regulatory requirements company/client`s standard operating procedures.
Summary of accountabilities:
- Liaising with project teams to procure documents required for regulatory submissions
- Management of preparation, review and coordination of Regulatory submissions on a country level
- Act as a key contact on a country level for all submission related activities and provide oversight for assigned projects
- Management of the submission documents country adaptation if requested
- Tracking and reporting of projects` progress through applicable Company systems
- Perform the role of Local Reviewer in the QC process of the submissions as appropriate
- Providing consultancy to the projects teams on any country regulatory specifics if requested
- University degree in Life Sciences or Pharmacy is preferred
- Good knowledge of applicable ICH Guidelines and applicable national regulatory requirements
- Good understanding of the drug development process
- Relevant regulatory experience with any types of submissions or experience in Clinical Research is preferred
- Demonstrated ability to multi-task and work effectively in a fast-paced environment
- Strong communication skills and fluency in written and spoken Ukrainian and English
- Ability to work as a team player, focusing on solving projects issues in team-oriented environment
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com
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