REGULATORY AFFAIRS MANAGER
SIRE 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!
Our client is a professional Biotechnology and Pharmaceutical organization, based in Flevoland Netherlands.
The company is a specialty pharmaceuticals leader, they develop, manufacture, market and distribute specialty pharmaceuticals and therapies.
They provide treatments to underserved patient populations within ophthalmology, rheumatology, pulmonology, nephrology, and neurology.
As a regulatory affairs manager you will be responsible for ensuring that products meet legislation to control safety and usefulness of the product from the early stages to bringing together for approval and registration.
- Support the execution of global registration and regulatory strategy
- Clinical development / support during the introduction of a product
- Maintain the life cycle management of the clients existing products
- Create and manage product information/labelling text for templates
- Develop project requirement specifications and manage all aspects of the project work
- Maintaining regulatory files and records of contact with Regulatory Authorities
- Maintain up-to-date knowledge of relevant regulations EU and US
- Master degree (or higher) in a scientific field
- A minimum of 10 years’ experience in regulatory affairs in a pharmaceutical or biotech industry
- SOP / GCP / GMP
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Experience with therapeutics such as gene, biologics, vaccines, and nuclear medicine
- Good experience with demonstrated people management
- Excellent communication skills in Dutch and English