RA Manager - Team leader
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 Pharmaceutical organization, based in Brussel Belgium.
Our client is a fast growing Consumer healthcare industry.
ROLE DESCRIPTION
As a team leader Regulatory Affairs you will lead a dedicated team of Regulatory Affairs Specialists, being a part of the Corporate Regulatory Affairs organisation.
RESPONSIBILITIES
- Regulatory support of strategic projects and co-ordination of regulatory activities related to the portfolio evaluated, developed and marketed for a group of products from the Consumer Healthcare portfolio
- Participation in CHC project evaluations, steer and lead all regulatory activities
- Input and advice for cross functional Teams on all relevant regulatory aspects
- Evaluation of in-licensing opportunities incl. review of external registration dossiers.
- Review and compilation of dossiers for regulatory submissions, e.g. Clinical Trial Authorisation applications, briefing package for meetings with Health -Authorities and Marketing Authorisation applications
- Regulatory input and co-ordination of responses to Health Authority requests for ongoing submissions and marketed products related to the strategic well-being portfolio.
- Coordination of respective product defence activities
REQUIREMENTS
- Graduate degree in a scientific discipline (Bachelor or higher)
- Experience with regulatory aspects of CHC drug development, registration and product maintenance
- Experience with handling MRPs and DCPs
- Excellent understanding of regulatory practices
- Good communication and writing skills in Dutch and English
- Ability to think strategically
- Experience with leading interdisciplinary teams
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
