Senior 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 Zuid-Holland Netherlands.
o Collection of information and preparation of dossiers
o Evaluation of the CMC data
o Creation of the product information texts
- Submitting the registration dossiers, responses, renewals and variation packages
- Coordinating the regulatory activities
- Contributing to the agreed way of document management
- Contributing to write and review the SOP’s
- Keeping excellent proactive relationships of DSP customers in order to maximize chances of approval.
- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English
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.
The Company
A global leader in sustainable antibiotics. Today they develop, produce and sell API's and DP's.Role Description
As Registration Professional you can hit the floor running, start as soon as possible and work fulltime for a period of one year.Responsibilities
- Preparing, compiling and maintaining the registration dossiers:o Collection of information and preparation of dossiers
o Evaluation of the CMC data
o Creation of the product information texts
- Submitting the registration dossiers, responses, renewals and variation packages
- Coordinating the regulatory activities
- Contributing to the agreed way of document management
- Contributing to write and review the SOP’s
- Keeping excellent proactive relationships of DSP customers in order to maximize chances of approval.
Requirements
- HBO or academic (WO) level- Experience within the pharmaceutical (generic) industry min 2 years
- Keeping updated knowledge of relevant new/draft legislation/regulation/guidance in the global regulatory affairs environment and apply them if required for pharmaceutical compliance.
- Working proficiency in English
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.
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