Regulatory Affairs Manager
Location: NetherlandsSIRE 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 Gelderland Netherlands.
Our client is a leading multinational company with focus on innovative and high-quality medicines and generic drugs.
ROLE DESCRIPTION
As Regulatory Affairs Manager you ensure that products meet legislation to control safety and usefulness from early stages towards final submission and approval.
RESPONSIBILITIES
- Responsible for global registration and regulatory strategy
- Clinical development - support during the introduction of new products
- Maintain life-cycle management of the existing products
- Product information and labelling texts
- Liaise with health authorities
- Maintain up-to-date knowledge of relevant RA guidelines in EMEA
REQUIREMENTS
- MSc. degree in Life Science or equivalent
- min. 6+ years experience in pharmaceutical industry
- Knowledge of GCP/GMP
- Profound knowledge of international legislation and regulatory guidelines
- Good people management
- Fluent 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 Anja Paetel.
