Freelance RA Manager
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 and Biotechnology organisation, based in Zuid-Holland Netherlands.
- Maintaining regulatory files and records of contact with Regulatory Authorities
- Stay up-to-date with knowledge of relevant regulations
- Provide support to the execution of global registration and pharmaceutical development strategies
- Management of strategic and technical support during the introduction of the products
- Uphold the life cycle management of the clients current product line
- Create and manage product information/labelling text for templates
- A minimum of 2 years experience in regulatory affairs
- Good experience with Diabetes, Cardiovascular a plus
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Excellent communication skills in English, and Dutch
The Company
The company its medical and scientific expertise contributes to high quality medical input, continuing the growth of their company.Role Description
As a RA consultant you will be involved in the preparation of regulatory submission and ensure that these are followed up and are updated in the system, this all on a freelance basis.Responsibilities
- Advance project requirement specifications and manage all aspects of project work- Maintaining regulatory files and records of contact with Regulatory Authorities
- Stay up-to-date with knowledge of relevant regulations
- Provide support to the execution of global registration and pharmaceutical development strategies
- Management of strategic and technical support during the introduction of the products
- Uphold the life cycle management of the clients current product line
- Create and manage product information/labelling text for templates
Requirements
- Bachelor degree (or higher) in life science- A minimum of 2 years experience in regulatory affairs
- Good experience with Diabetes, Cardiovascular a plus
- Good knowledge of international legislation, and thorough understanding of drug and biologics guidelines and regulations
- Excellent communication skills in English, and Dutch
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