Regulatory Affairs Scientist
Location: NetherlandsSIRE 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 Noord-Holland Netherlands.
Our client belongs to the largest vaccine companies worldwide. Their focus is primarily on research and development, with manufacturing plants across Germany, UK and USA.
ROLE DESCRIPTION
Are you looking for a rewarding career in a market-leading and innovative company?
As Regulatory Affairs Scientist you ensure regulatory compliance by being in contact with regulatory authorities and compiling all submissions within the relevant documentation management systems.
RESPONSIBILITIES
- Development and implementation of the global regulatory strategy
- Regulatory risk assessment
- Assist in the product application process including IND, BLA/MAA
- Ensure that submissions are clear, well written and communicate the company position accurately
- Support product labelling (PI, CMI, SmPC, PIL etc.)
- Provide regulatory expertise and guidance for the development and review of technical and clinical reports
- Update and maintain regulatory tracking database
- Build and maintain relationships with Global Regulatory Affairs colleagues across the company
- Deputy of Senior/Principal RA Scientist when required
REQUIREMENTS
- Master or PhD in Biological Science, Medical discipline or Pharmacy
- min 1 year regulatory affairs experience, or related biologicals/ pharmaceutical industry experience
- Demonstrable experience in a complex global matrix environment
- Customer service focus
- Strong planning, organizing and time management skills
- Computer literacy
- Fluency in English (both verbal and written)
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.
