Regulatory Affairs Specialist
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 Zuid-Holland Netherlands.
Our client is a professional Pharmaceutical organization, based in Antwerpen Belgium. The client's research and development centre develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
ROLE DESCRIPTION
You will provide strategic global regulatory advice within Regulatory Affairs and research and manufacturing organisations specific to the area of Chemistry, Manufacturing and Control (CMC). Your primary responsibility is to support pre- and post-approval products.
RESPONSIBILITIES
- Interpret and applicate global CMC regulations and guidance within the context of your project's boundaries.
- Ensure the fitting CMC activities happen in support of the timely submissions.
- You provide strategic regulatory advice and review of submissions made to worldwide Health Authorities.
- Also, you provide regulatory advice for regulatory assessment of changes for assigned products.
- Lastly, you provide strategic and timely input to responses to questions and issues raised by Health Authorities during their review of these submissions.
REQUIREMENTS
- A minimum of a Bachelor's degree and 6 or more years of relevant pharmaceutical industry experience within chemistry pharmacy disciplines or related,
- OR an advanced degree (MSc, PhD, etc.) and a minimum of 4 years or more relevant experience is required.
- CMC experience is nice to have. Basic knowledge of RA is required.
- Drug development experience is a nice to have. Working knowledge of global RA laws, regulations, and guidances is required.
- Impeccable English is a must
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.
