PRA Health Sciences are a Clinical Research Organisation committed to developing our people.
This role offers the right candidate the opportunity to join a fast growing and developing Global Regulatory Affairs team. The Local Regulatory Affairs Associate (LRAA) 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.
For this role, we are open to applications from entry-level profiles (graduate or PhD graduate candidates), or experienced professionals.
To be considered for this role, you will have the following:
- An undergraduate or postgraduate degree ideally in a life-sciences discipline
- For entry-level candidates, a genuine interest to forge a career in regulatory affairs
- For experienced candidates, prior working experience of central Ethics Committee submissions
- Knowledge of current ICH and local Regulatory Agency and Ethics Committee regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development.
- 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.
To apply for this job please visit careers-prahs.icims.com.