Regulatory Affairs Director
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.
A biopharmaceutical clinical-stage company, specialized in the development and engineering of cell-based therapies.
ROLE DESCRIPTION
The successful candidate will report into the Global Head Regulatory Affairs (located in the US)
RESPONSIBILITIES
- Stay up to date with regulatory requirements relevant for company pipeline/products
- Develop detailed regulatory project plans and timelines
- Participate as an active team member and provide strategic regulatory advice to cross-functional program and project teams as required on all aspects of Regulatory CMC, non-clinical and clinical aspects during all stages of drug development
- Manage and oversee responses to regulatory authorities’ questions with strict deadlines
- Serve as a liaison with relevant Health Authorities
- Ensure optimal early interactions with relevant Regulatory Agencies and identification and mitigation of regulatory gaps
- Review and provide Regulatory insight into submission-level documents to ensure alignment with company objectives and strategy
REQUIREMENTS
- Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 8 years in biopharmaceutical / pharmaceutical / biotech industry, in a similar role in Regulatory Affairs; or a PhD in Pharmaceutical Sciences, Life Sciences or equivalent with at least 5 years in biopharmaceutical/ pharmaceutical / biotech industry, in a similar role in Regulatory Affairs
- Experience in coordination, preparation and conduction of global regulatory agency meetings and related materials
- Solid understanding of regulations and guidelines
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.
