Regulatory Affairs Sr. 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 Waals-Brabant Belgium.
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ROLE DESCRIPTION
As a senior regulatory affairs associate you will be responsible for the development of regulatory strategies and maintain authorization for products. You will also be responsible for the communication of requirements for licensing of products.
RESPONSIBILITIES
- Submission of regulatory documents in accordance with requirements
- Preparation of SOP´s
- Ensure that regulatory files are in the correct format with requirements
- Provide support in regulatory activities
- Maintenance of regulatory authorization
- Actively participate in the regulatory affairs team and provide regulatory advice to team members
REQUIREMENTS
- Bachelor (master/PhD) degree in a scientific discipline
- 3-5 years experience with regulatory affairs
- Experience in a pharmaceutical environment (or similar)
- Excellent communication skills in English
- Knowledge of legislation/regulations European and international
- Able to handle stress and strickt deadlines
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Linn Andenes.
