RA Freelance Professional
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 drives innovation in Diabetes Research and is a professional Pharmaceutical organization, based in Brussel Belgium. For more than 90 years they are an innovative key player concerning diabetes care. This history offers them the experience and the capacity that enables them to help people with other severe chronic ailments like: hemophilia, growth disorder and obesity.
ROLE DESCRIPTION
The consultant provides regulatory guidance and expertise in the field of biological products to clients. Aid clients in the preparation, review and management of regulatory documents such as investigational medicinal product dossiers (IMPD) and Module 3 of registration dossiers in the various steps of the registration process. You will be responsible for all communications to the regulatory authorities during the process and participate in meetings between the client and regulatory authorities.
RESPONSIBILITIES
- Provide medical expertise in scientific publications and provide a good overview of different projects on diabetic
- Participation in discussions with stakeholders in order to provide relevant data.
- Prepare and take part in investigator meetings and study result presentations.
- Work together with stakeholders to develop a medical plan for medical studies
- Have oversight of all medical activities for Diabetes
REQUIREMENTS
- have an academic degree in life or pharmaceutical sciences.
- a minimum of 5 years experience in regulatory affairs.
- excellent knowledge of European procedures and guidelines.
- able to adjust scientific information to the regulatory framework with good communication skills to scientific experts.
- capable of building good relationships with clients.
- excellent communication skills in Dutch and French.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
