Director Regulatory Affairs
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 Biotechnology and Pharmaceutical organization, based in Zuid-Holland Netherlands.
The company uses its medical and scientific expertise for high quality medical input in all phases of the lifecycle of their products, continuing the growth of their company.
ROLE DESCRIPTION
As a regulatory affairs director you will be responsible for implementing the regulatory strategy.
RESPONSIBILITIES
- Make sure that regulatory submissions comply with relevant regulations and guidelines
- Be one of the leading actors in the development of the company´s strategy focussing on regulatory aspects
- Prepare regulatory applications
- Close communication with internal and external partners (EMA, FDA)
- Ensure that you are up-to-date concerning changes in regulatory legislation and communicate findings to other staff members
REQUIREMENTS
- Master degree (or equivalent) in a scientific discipline
- Excellent communication and writing skills in English and Dutch
- Good negotiation skills
- Excellent knowledge of European regulatory legislation
- Strong leadership skills, strategical reasoning skills and being able to critically evaluate risks
- Experience with orphan dugs is preferable
- Ability to prioritise between multiple tasks in a fast pace environment
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
