Regulatory Affairs Officer with clinical background
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 Utrecht Netherlands.
You will be supporting the Global RA Director, bringing clinical experience in the field of RA.
- Understanding of and experience with the registration procedures for APIs in the EU/America area is a necessity.
- Change management internally as well as externally by supporting customers.
- Regular review of current and upcoming guidelines and their compliance.
- You have at least 3 years of experience in Regulatory Affairs of APIs
- Be familiar with the registration procedures and requirements in the USA and the EU
- Experience with compiling relevant registration dossiers in e-CTD format
The Company
The company is a global leading manufacturer of Generics wile undergoing a shift to becoming a more innovative company.Role Description
As RA officer you will be responsible to make business possible for our client by obtaining approvals for API registration dossiers (directly or via their customers) in the markets of the Business Unit Europe/ America like EU, Eastern Europe, US and China, and Canada.You will be supporting the Global RA Director, bringing clinical experience in the field of RA.
Responsibilities
- Preparation, submission and maintenance of API registration dossiers, performed in cooperation with RA managers of BU EA as well as other Business Units, API manufacturing sites, RA consultants.- Understanding of and experience with the registration procedures for APIs in the EU/America area is a necessity.
- Change management internally as well as externally by supporting customers.
- Regular review of current and upcoming guidelines and their compliance.
Requirements
- Academic degree in Chemistry (prefered) or Pharmacy field.- You have at least 3 years of experience in Regulatory Affairs of APIs
- Be familiar with the registration procedures and requirements in the USA and the EU
- Experience with compiling relevant registration dossiers in e-CTD format
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