REGULATORY AFFAIRS 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 Brussels Hoofdstedelijk Gewest Belgium.
- Generate a good understanding of the regulatory compliance
- Maintain product registration approvals by ensuring compliance with regulatory requirements and work closely together with Global Regulatory Affairs
- Contribute with regulatory submissions (e.g. DMFs, CEP applications) while collaborating with other functions involved
- Collaborate with Global Regulatory Affairs
- To update and be up-to-date on regulatory legislations, including local regulations and communicate this effectively
- Minimum of 3 years of experience in the medical affairs in the pharmaceutical industry,
- Experience and knowledge in the pharmaceutical industry, preferably in Regulatory Affairs (CMC)
- Excellent communication and writing skills in French and English
- Experience in leading a team, delegating and decision-making
- Good technical writing skills
The Company
Our client is a professional Pharmaceutical organization, based in Brussel Belgium. As a worldwide leader supplying the pharmaceutical and biotechnology industries with biopharmaceuticals.Role Description
As a regulatory affairs manager you will be responsible for the regulatory strategy and global regulatory deliverables for the company.Responsibilities
- Coordination and planning regulatory submissions with management and departments regarding the overall planning to meet customers and project timelines- Generate a good understanding of the regulatory compliance
- Maintain product registration approvals by ensuring compliance with regulatory requirements and work closely together with Global Regulatory Affairs
- Contribute with regulatory submissions (e.g. DMFs, CEP applications) while collaborating with other functions involved
- Collaborate with Global Regulatory Affairs
- To update and be up-to-date on regulatory legislations, including local regulations and communicate this effectively
Requirements
- Minimum bachelor degree in life science related field,- Minimum of 3 years of experience in the medical affairs in the pharmaceutical industry,
- Experience and knowledge in the pharmaceutical industry, preferably in Regulatory Affairs (CMC)
- Excellent communication and writing skills in French and English
- Experience in leading a team, delegating and decision-making
- Good technical writing skills
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