Regulatory Affairs Associate
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.
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ROLE DESCRIPTION
As a regulatory affairs associate you will be responsible for the registration of new products and make sure that the products are compliant with the regulatory requirements. The Regulatory Affairs Associate will be involved in developing and implementing regulatory strategies for the EMEA region and take ownership on all regulatory tasks for this specific region. This will involve responsibilities for registering new products and ensuring compliances with regulatory requirements, as well as maintaining product registration approvals by ensuring compliance with legal authoritites
RESPONSIBILITIES
- Develop and implement regulatory strategies for the EMEA region
- Maintain product registration approvals by ensuring compliance with regulatory requirements
- Contribute with regulatory submissions and prepare registration dossiers
- Act as a regulatory liaison with the R&D and marketing department for the development of regulatory plans
- Implementation of the regulatory strategy in order to achieve approval for both new and existing products
- Be up-to-date on regulatory legislations, including local regulations and communicate this effectively
- Generate a good understanding of the regulatory requirements (EMEA)
- Establish relationships within the EMEA region including governmental departments
REQUIREMENTS
- University degree (Bachelor/Master) in (Bio)chemistry
- Good knowledge of chemical substance identification
- A minimum of three years of experience is required
- Excellent communication and writing skills in English
- Experience with Regulatory Science or Affairs in the EMEA region (preferred)
- Experience in working in teams
- Good technical writing skills
- Being well-organised and structured, and able to deal with stress and strict deadlines
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
