Regulatory Affairs CMC 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 Pharmaceutical organization, based in Antwerpen Belgium.
They are dedicated to bring innovation to global health. Their team focusses on discovering, developing, manufacturing and marketing of vaccines. Their mission is to protect people from infectious diseases.
ROLE DESCRIPTION
You will be responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. Manage and technical supervision for the assembling of CMC dossiers. Accountable for the solutions.Ensures all RA submissions are completed in a timely manner.
RESPONSIBILITIES
Manage the production of sections of the CMC dossier and evaluate that submissions are compliant with RA directories.
Ability to manage complex systems simultaneously
Excellent written, verbal communication and presentation skills
Able to manage relations with key stakeholders
Build a relevant network by attending professionally relevant conferences
REQUIREMENTS
MSc. in Chemistry, Pharmacy or related science
Minimum of 2 years pharmaceutical industry experience
Vaccine experience is a plus
Fluent in English and Dutch or 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.
