Freelance Junior Regulatory Affairs Officer
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 Noord-Holland Netherlands.
An interesting and growing pharmaceutical company who has sites on multiple locations worldwide. Their main objective is to improve humans health and research incurable diseases.
As part of the growth of the company, they require the skills of an additional Regulatory Affairs Officer to reduce the current work pressure of the team. You will be responsible for dossiers of the company, provide regulatory information, write reports etc. and in this way perform according to the requirements
- Be involved in international projects, and operate according to the regulatory requirements;
- Collaborate with different departments to identify and assess key regulatory requirements, regulations and information;
- Write technical regulatory reports and thereby be responsible for compiling dossiers;
- Evaluate regulatory information for relevance and its impact to the company internal processes;
- Analyze and monitor external regulatory environment, including guidance and regulations from regulatory authorities;
- Up to date knowledge of regulation and trends to determine and supply for guidance as needed;
- Work together in a team of regulatory experts and have contact with the clients;
- Manage strict deadlines
- MSc. in the life science (preferably pharmaceutical background);
- 2 years + Experience in Regulatory Affairs position in the pharmaceutical industry;
- Hands-on experience with technical writing is a must;
- Excellent command of English;
- Communication skills.