||SIRE Life Sciences(R) 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(C) to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment(C): 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(C), making sure we, or better yet, you find the right career!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Belgium.
The company is a growing international organization specialized in the development and production in pharmaceutical products. They specialize in the field of hematology.
In the role of regulatory affairs manager you'll be responsible for ensuring that products meet legislation to control their safety and efficacy from early development to the coordination of approval and registration.
- Ensuring the compliance of documentation from different regions
- Prepare, coordinate and plan regulatory submissions (e.g. DMFs, CEP applications) in accordance with relevant regulations
- Coordinate and maintain the life cycle management of the clients existing products
- Develop project requirement specifications and manage all aspects of the project work
- Maintaining regulatory files and records of contact with Regulatory Authorities and Health Authorities
- Maintain up-to-date knowledge of relevant regulations
- Minimum bachelor degree in life science related field
- A minimum of 3 years experience in regulatory affairs in a pharmaceutical or biotech industry
- Experience and knowledge in pharmaceutical industry, preferably with CMC Regulatory Affairs environment
- Excellent communication skills in English and Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.