Regulatory Affairs Officer/Specialist
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 Pharmaceutical organization, based in Brussel Belgium.
Our client is the market leader on generic products in Belgium.
ROLE DESCRIPTION
As a Regulatory Affairs Officer you will be responsible for managing the life cycle of the drugs from the preparation of the registration dossier to the launch of the registered drug on the market.
RESPONSIBILITIES
- Managing registrations
- Preparing, submitting and following up administrative barriers on demand of the FAGG within the statutory time limits.
- Evaluate, analyse and prepare variation files that give rise to changes in CTD Module 3 (change controls)
- Checking and approval of packaging materials SPC, PIL
- Keeping the RIMS (Regulatory Information Management System) up-to-date
- Providing scientific support regarding pharma-technological questions.
- Acquiring and maintaining knowledge of laws and regulations
- The use of these procedures and work instructions as part of the overall quality of the company
REQUIREMENTS
- Pharmacist or Master degree in Pharmaceutical sciences
- 1+ years of experience with Regulatory Affairs
- Good organisation skills and an eye for detail
- Knowledge and or experience with the Belgian Authorities is preferred
- Fluent in Dutch and English (French is also preferred)
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
