Interim RA consultant
SIRE 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!
Our client is a professional Medical Devices and Pharmaceutical organization, based in Belgium.
A big player whom came to Belgium when they first ventured out of the US. Their choice for Belgium was for the strategic position in the heart of Europe. The company is an economic and socially important actor that is aware of its responsibilities and in Belgium puts more than 1.300 people to work and generates around 4.000 indirect jobs.
As an interim regulatory affairs manager you will be responsible for ensuring that products meet legislation to control their safety and efficacy in the coordination of approval and registration. Your focus will be on legislation in the Gulf States.
- Support the execution of regional registration
- Support/manage strategic and technical support during the registration of products
- Update the life cycle management of the clients existing products
- Create and manage product information/labelling text for new templates
- Develop project requirement specifications and manage all aspects of the project work
- Maintaining regulatory files and records of contact with Regulatory Authorities
- Maintain up-to-date knowledge of relevant regulations EU and Middle eastern
- Bachelor degree (or higher) in a scientific field
- A minimum of 3 years’ experience in regulatory affairs in a pharmaceutical or biotech industry
- Good experience with CMC
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Experience with therapeutics such as gene, biologics or vaccines
- Excellent communication skills in English