Regulatory affairs consultant
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 Brussel Belgium.
The company is one of the world's leading biotechnology companies.
ROLE DESCRIPTION
As a regulatory affairs consultant you will be responsible for the coordination and execution of regulatory submissions in compliance with regulatory requirements.
RESPONSIBILITIES
- Ensure regulatory submissions
- Contribute to and execute the filing plan
- Review source text for country labeling
- Review promotion and non-promotion materials
- Maintain an awareness of & ensure local management are kept up to date on new & developing local legislation & regulatory policy
- Disseminate relevant information to team(s) as appropriate
- Participate in local regulatory process improvements initiatives
- Assist locally in Healthcare Compliance activities where applicable
- Coordinating and reviewing briefing documents
- Coordinating translation for local Regulatory submission.
REQUIREMENTS
- Master degree in a life science discipline or a bachelor degree in a scientific discipline including at least 2 years related experience
- Fluency in English (in addition to either Dutch or English)
- Good communication skills
- Excellent organizations skills
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
