Regulatory Affairs Associate (Study Start-up)
- Experience Level
- Experienced (non-manager)
We don’t tell our employees what they should care about. They tell us.
At PRA, Philanthropy, charitable giving and social responsibility are more than buzz words for us – they’re ideas we hold up as ideals. Our passion and commitment to improving lives extend far beyond our work and we believe that it is our obligation to empower our employees to find meaningful ways to respond to the needs of others around the world.
This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Regulatory Affairs Associate (RAA) manages the activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.
Summary of tasks:
- Management of country level submissions associated with ensuring Investigational Product and any other clinical trial supplies can be imported / exported into/from the country the LRAA is responsible for.
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
- Management of the country level Informed Consent and any other documentation given to patients through to submission and approval by country level RA and Central IEC as appropriate.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
- Perform role of Local Reviewer in the QC process as appropriate.
- Providing consultancy to the client on any country specifics issues if requested.
A quality focused self-starter with ambition to learn and develop.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- An undergraduate degree ideally in science, or health-related field.
- Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical product development. Ideally + 2 years of experience in submissions to agency and Ethics Committee.
- The ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
- Strong communication skills and fluency in written and spoken English
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.
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