SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Luik Belgium.

The Company

A Global pharmaceutical organisation with steady growth and 7000+ colleagues on their Benelux Campuses. You will be working for a new regional organisation, created to handle local organisational activities.

Role Description

You will work in close collaboration with local organisations. Mostly focusing on the maintenance of existing registrations, keeping all existing products up to date.

Responsibilities

Lead and facilitate CMC variation / label change processes
Coordinate submission plan
Facilitate complete dossiers based on local regulations
Update related EMEA CMC processes
Assess and implement label changes

Requirements

Good regulatory experience in drug development
Experience and knowledge with/of local regulations and guidances of drug life cycle EU wide
Knowledge of the scientific principles
Awareness of quality and supply chain
Solid RA submission process knowledge