Regulatory Affairs Specialist
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 Waals-Brabant Belgium.
A multinational operating company in the field of pharmaceutical and medical products. The company's mission is to expand access to care by providing cost-effective solutions and delivering high quality and innovative products.
ROLE DESCRIPTION
In this role you will be mainly responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for the company's products.
RESPONSIBILITIES
- Compile and submit regulatory documents
- Prepare review and approve labeling and SOP's
- Contact person for regulatory authorities
- Maintain regulatory database
- Provide guidance and coaching to lower level team members
- Project Management
REQUIREMENTS
- BSc. in pharmacy or related scientific discipline. Higher degree/PhD will be a plus
- 5+ years industrial experience in Regulatory Affairs
- Excellent command of English (both verbal and written)
- Good knowledge of MS Office, Outlook, Sharepoint
- Experience with Trackwise and BaxEdge 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 Anja Paetel.
