Regulatory Affairs Associate - Clinical Trials

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 systems.
Perform role of Local Reviewer in the QC process as appropriate.
Providing consultancy to the client on any country specifics issues if requested



Qualifications:


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 and Swedish