Regulatory Affairs Project Manager
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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 organisation, based in Liège Belgium.
Preparation and maintenance of necessary dossiers
Keep track of regulatory trends and changes, and address them accordingly
Evaluate current processes while improving efficiency and implementation of new regulations
Contact with RA stakeholders including customers, regulatory authorities, scientific experts etc.
Over 7 years of experience in RA of biopharmaceuticals
Good background in submissions and registration processes
Knowledge of US and EU guidelines in regard to medicines
Fluent in English, French and Dutch
Thorough knowledge of cGxP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Nicolas Gyselinck.
The Company
Our client is a big healthcare organisation based in Liège, Belgium. They have been one of the world's leading suppliers in pharmaceutical and biotechnological solutions. They are currently looking for a new project manager for their regulatory activities.Role Description
As the RA Project Manager, your goal is to make sure all the products are compliant to the applicable regulations of the different international and local authorities.Responsibilities
Provide regulatory support to the site and to customersPreparation and maintenance of necessary dossiers
Keep track of regulatory trends and changes, and address them accordingly
Evaluate current processes while improving efficiency and implementation of new regulations
Contact with RA stakeholders including customers, regulatory authorities, scientific experts etc.
Requirements
Minimum BSc degree in biological sciences, (bio)chemistry or something relatedOver 7 years of experience in RA of biopharmaceuticals
Good background in submissions and registration processes
Knowledge of US and EU guidelines in regard to medicines
Fluent in English, French and Dutch
Thorough knowledge of cGxP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Nicolas Gyselinck.
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