CMC Regulatory Affairs Consultant
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.
The company is an international orientated pharmaceutical company with a large drug portfolio in different therapeutic areas
ROLE DESCRIPTION
You will be responsible for writing scientific documents and regulatory reports (MADs, IMPDs, Variations, etc.). You ensure full compliance with regulatory requirements. You are reporting to the Regulatory Affairs CMC Manager.
RESPONSIBILITIES
Analyze data scientifically and statistically
Write technical customer reports as well as CMC regulatory documentation
Solve problems and issues by offering practical solutions that are compliant with regulatory requirements
Follow-up on dossiers after submission
Remain up-to-date on all new laws and regulations concerning pharmaceuticals
REQUIREMENTS
You have a Masters degree in a chemical or pharmaceutical discipline (bio-engineer, pharmacist, chemist,
); a PhD degree is advantageous
You have experience with writing the CMC module of regulatory dossiers of chemical and/or biopharmaceutical drugs
You have excellent writing and presentation skills with attention to detail and accuracy
Youre able to handle multiple projects and to adapt to changing priorities
Youre a team player
Youre fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
