Senior Manager Regulatory Affairs
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Brussels Hoofdstedelijk Gewest Belgium.
- Serve as a Regulatory Program Lead for one or more of the products of the Immuno-Oncology pipeline and responsible for planning
- Contribute to the implementation of innovative global regulatory strategies (focus EU and US) for novel early-stage genetically modified cell-based cancer
- Writing of Regulatory documents and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions
- Stay up to date with regulatory requirements relevant for company products
- 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
- Global Regulatory expertise in Oncology, Immuno-oncology, Cell Therapy, Gene Therapy, or Biologics Development; global expertise in Device or Combination Product Development desirable
- Experience in coordination, preparation and conduction of global regulatory agency meetings and related materials
- Solid understanding of regulations and guidelines
The Company
Our client is a professional Pharmaceutical organization, based in Brussel Belgium. Brings breakthrough pioneering therapies to patient with life threatening diseases.Role Description
The successful candidate will be based in Brussels (Belgium) or Boston (USA) and will report to the Global Head Regulatory Affairs (located in the US)Responsibilities
- Work with Regulatory Affairs management to develop innovative regulatory strategy, compile and submit regulatory documents to Health Authorities- Serve as a Regulatory Program Lead for one or more of the products of the Immuno-Oncology pipeline and responsible for planning
- Contribute to the implementation of innovative global regulatory strategies (focus EU and US) for novel early-stage genetically modified cell-based cancer
- Writing of Regulatory documents and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions
- Stay up to date with regulatory requirements relevant for company products
- 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
Requirements
- Master in Pharmaceutical Sciences, Life Sciences or equivalent with at least 5 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 3 years in biopharmaceutical/ pharmaceutical / biotech industry, in a similar role in Regulatory Affairs- Global Regulatory expertise in Oncology, Immuno-oncology, Cell Therapy, Gene Therapy, or Biologics Development; global expertise in Device or Combination Product Development desirable
- Experience in coordination, preparation and conduction of global regulatory agency meetings and related materials
- Solid understanding of regulations and guidelines
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