Manager, Regulatory Affairs Hematology
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.
Our client is a global biopharmaceutical leader in the development and manufacturing of chronic conditions.
ROLE DESCRIPTION
As a regulatory affairs manager you will be responsible for the regulatory strategy and global regulatory deliverables for the company.
RESPONSIBILITIES
- Provide guidance, direct and lead a team of regulatory professionals
- Liaison relationships with regulatory authorities
- Ensure that the regulatory strategy is aligned with the business strategy
- Be up to date on national and international legislation
- Being responsible for the content and standard of regulatory submissions
- Manage budget
- Be the single point of contact with regulatory authorities
REQUIREMENTS
- Master/Ph.D. in a scientific discipline
- Excellent knowledge of the regulations, and experience with interpretation and application
- Excellent communication and writing skills in English, Dutch and French
- Good presentation skills
- Strong negotiation skills and the ability to come to good agreements with regulatory authorities
- A minimum of five years experience working in a pharmaceutical/biotech environment
- Good problem solving skills
- Experience with managing people
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
