Senior RA specialist
Location: NetherlandsSIRE® 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 Noord-Brabant Netherlands.
You are responsible for guiding colleagues through processes, while develop parallel processes. Experience with EU submissions and knowing how to handle variations from different regions are paramount in order to successfully lead the projects.
- 3+ years of regulatory experience in various EMEA regions
- In depth knowledge of local regulations
- Individual worker, however you need to be able to communicate clearly with other people attached to the project.
- Experience with RA tracking systems like MPD, SPS or Trackwise
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Naut van Osnabrugge.
The Company
Our client is a subsidiary of a global pharmaceutical company.Role Description
As the senior specialist you are responsible for the existing products of the company in the EMEA region. The group handles CMC variations and labeling changes. You have global RA members that report to you from different regions.Responsibilities
You are responsible for all CMC and label variations; plan and prepare the strategy for submissions and prepare the dossiers per regional company.You are responsible for guiding colleagues through processes, while develop parallel processes. Experience with EU submissions and knowing how to handle variations from different regions are paramount in order to successfully lead the projects.
Requirements
- Advanced degree preferred- 3+ years of regulatory experience in various EMEA regions
- In depth knowledge of local regulations
- Individual worker, however you need to be able to communicate clearly with other people attached to the project.
- Experience with RA tracking systems like MPD, SPS or Trackwise
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Naut van Osnabrugge.
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