Regulatory Affairs 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 organisation, based in Noord-Holland Netherlands.
Organizes the preparation, submission and follow-up of authorities (MAA).
Organizes and archives registration files.
- Contributes to process improvements
- Typically resolves problems using existing solutions
- Provides informal guidance to junior staff - Works with minimal guidance
- Solves complex problems; takes a new perspective using existing solutions
- Works independently; receives minimal guidance
- Acts as a resource for colleagues with less experience
- Academic working level, minimum of 5 Yrs of related experience.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
Role Description
Leads small group of experienced RA specialists/associates. Empathy with commercial processes, strategic planning together with RA Director and other RA Manager.Responsibilities
Plans and manages regulatory activities on both new and in-line products in accordance with health authorities.Organizes the preparation, submission and follow-up of authorities (MAA).
Organizes and archives registration files.
- Contributes to process improvements
- Typically resolves problems using existing solutions
- Provides informal guidance to junior staff - Works with minimal guidance
- Solves complex problems; takes a new perspective using existing solutions
- Works independently; receives minimal guidance
Requirements
- Requires in-depth knowledge and experience of Module 3 variations, incl. eCTD publishing- Acts as a resource for colleagues with less experience
- Academic working level, minimum of 5 Yrs of related experience.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
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