Regulatory Affairs Associate
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Belgium.
The company is a leading pharmaceutical company who is operating worldwide.
ROLE DESCRIPTION
You will be working in a team where your daily activities will include submission of regulatory documents directly to the FDA and perform in day-to-day activities of the company. There are lots of possibilities to develop yourself in the RA area and on personal notion.
RESPONSIBILITIES
- Compiling, preparing, and submitting routine regulatory submissions
- Provide support for various regulatory submissions to the FDA and other regulatory agencies
- Interacting with different departments to gather data and documentation for the submissions
- Assist in developing draft labeling for the company products
- Be up-to-date with the regulatory guidelines to maintain Regulatory Affairs department files and be compliant
REQUIREMENTS
- Academic degree in life science
- Experience in the pharmaceutical industry
- Excellent communication and writing skills
- Being fluently in English, any other language is a plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.