Director/Manager RA - Orphan Drugs
Location: BelgiumSIRE 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 Clinical Research and Pharmaceutical organization, based in Flandre Orientale Belgium.
Our client is a leading player in the development of orphan drugs.
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, Dutch and French
- Good negotiation skills
- Excellent knowledge of European and American 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 Linn Andenes.