Regulatory Affairs
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.
- Provide national input to regulatory strategies
- Plan and manage local regulatory submission
- Ensure local labels are developed and maintained in line with local legislation
- Act as a main point of contact with regulatory agencies
- Knowledge of Regulatory principles
- Working with policies, procedures and SOP's
- Comprehensive understanding of Regulatory Activities
- General knowledge of EU/Dutch national legislation and regulations
- Understanding of drug development
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
The Company
The mission of this company is to help patients. Every day they fully commit to better the life of sick people. With a focus on results of the treatment they do scientific research, the development and creating the most effective medication.Role Description
The company is looking for a Regulatory Affairs professional who will provide local Regulatory Affairs Expertise on different products. You will review promotional materials, approving source text for country labeling and country artwork. Providing regulatory advice to local and regional teams upon request and acting as a point of contact for the regulatory authorities.Responsibilities
- Assist in aligning local regulatory requirements within company standard- Provide national input to regulatory strategies
- Plan and manage local regulatory submission
- Ensure local labels are developed and maintained in line with local legislation
- Act as a main point of contact with regulatory agencies
Requirements
- Bachelor's or Master's degree and two years' of experience- Knowledge of Regulatory principles
- Working with policies, procedures and SOP's
- Comprehensive understanding of Regulatory Activities
- General knowledge of EU/Dutch national legislation and regulations
- Understanding of drug development
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.
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