Regulatory & Medical Affairs Manager
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 Pharmaceutical organization, based in Brussel Belgium.
Our client is a leading company in health and hygiene.
As a regulatory & medical affairs manager you will be responsible for taking the lead for all regulatory obligations set by the regulatory management, and ensure that the company is in constant compliance with all local and international regulations.
- Ensure registration and regulatory compliance of products
- Alter registration dossiers in order to comply with country specific requirements
- Monitor submission of registration applications and negotiate with governmental authorities in order to ensure rapid approvals
- Give medical support to multidisciplinary teams in order to support marketing activities
- Help out in the preparation of responses to address significant safety and/or regulatory issues relating to products;
- Support internal investigations assertion of non-compliance and coordinate the activities resolve local regulatory conflicts
- Prepare, maintain and update product registration and regulatory compliance files
- University degree in Pharmacy or another Scientific discipline
- Good understanding of regulatory registration systems
- A minimum of four years experience in the pharmaceutical industry
- A minimum two years work experience with RA
- Excellent communication and writing skills in Dutch, English and French
- The ability to understand and interpret regulatory guidelines and communicate them thoroughly
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.