Regulatory Affairs Associate
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 Netherlands.
The client is dedicated to a future where healthcare will be challenged by entrusted patients. They want to improve access to medicines and related health care services to the people who need them.
ROLE DESCRIPTION
The Regulatory Affairs Associate is responsible for working with the other Regulatory Affairs team members and other departments on label changes and CMC variations, by performing specialized activities in the submission process for all countries within their cluster or even region.
RESPONSIBILITIES
- Timely preparation and approval of country records and related attachments on behalf of the representative
- Be responsible for mapping all relevant submission and approval documents
- Documenting import, handling and approval
- Assist in developing draft labeling for the company products
- Be up-to-date with the regulatory guidelines to maintain Regulatory Affairs department files and be compliant
REQUIREMENTS
- Academic degree in life science
- Experience in the pharmaceutical industry
- Excellent communication and writing skills
- Being fluently in Dutch and English, any other language is a plus
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.