EU-CH Regulatory Affairs Trainee

OM Pharma positioned itself as a local player to support students and young graduates in their first working experiences. We are therefore pleased to offer a paid internship starting ideally from April 2023 (according to your availability) for a period of 6 months minimum within our Regulatory Affairs team.

Your main responsibilities are as follows:

•   Support in the preparation and management of regulatory submissions for EU/CH for nationally registered medicinal products

•   Support in the preparation of responses to regulatory queries from regulatory authorities.

•   Liaise with Regulatory Affairs (RA) Chemistry Manufacturing & Control (CMC), Regulatory Operations & Support groups to collect all the information required for preparation of regulatory activities 

•   Ensure timely execution of regulatory activities as per the plan set up with the line manager

•   Develop knowledge and appropriate interpretation of guidelines, directives etc.

•   Support the RA team to maintain tracking tools and regulatory databases up to date

•   Provide appropriate support to the RA Brand & Development team members an on assigned tasks

To carry out this mission, we are looking for a person with the following profile:

•   Students under agreement with a school / start of mission from April 2023

•   In the process of completing a Master's degree /Certificate of advanced study in Clinical and Regulatory Affairs 

•   Excellent knowledge of Microsoft Office, especially Power Point & Excel

•   Fluent in English and French as an asset

•   Sense of organization

You are interested in regulatory affairs, eager to learn and contribute to our team’s activities and describe yourself as a multi-skilled, rigorous and easy communicator. 

If you are looking for an internship to gain first-hand experience in regulatory affairs where you will be involved in a wide range of projects and initiatives with global impact, apply! We look forward to receiving your application.