My Shortlist

Your shortlisted jobs will appear here. To view your shortlist: Login Or Register

Date Added: TODAY

Regulatory Affairs Associate

France (FR), France
Apply Now

Company: ICON

Job Type: Permanent, FullTime

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

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.

You are:

  • 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

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Apply Now