Regulatory Affairs Consultant
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 company is a big leading pharmaceutical within Europe. Moreover, the company is composed for further science, technology and new (commercial) product development.
ROLE DESCRIPTION
In this role you will work closely with the manager regulatory affairs and different departments. You will be responsible for global regulatory requirements (including CMC) for the development and registration of new medicinal products.
RESPONSIBILITIES
- Experience within the CMC submissions; preparing and submitting registration dossiers
- Ensuring deadlines by delivery of accurate final documents for the registration according to the regulations.
- Interplay between clients, governmental bodies and health authorities worldwide
- Maintain up-to-date knowledge of current government regulations and worldwide requirements applicable (EU, US and ICH) to every stage of the registration process
- Write, review and approve technical documents.
- Participate in project teams to provide for the regulatory information
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 English and Dutch
- Experience in leading a team, delegating and decision-making
- Good technical writing skills
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.
