Regulatory Affairs Project National Registrations
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Biotechnology organization, based in Zuid-Holland Netherlands.
The client's mission is to prevent, treat, cure and stop this times most complex diseases. They transform individual lives and change the treatments of diseases.
ROLE DESCRIPTION
It will be your responsibilities to register products in a timely manner in support of business growth and to maintain full compliance of products with regulatory requirements.
RESPONSIBILITIES
- Responsible for the registration/re-registration of a company or drug and post-approval variations
- Coordinates, compiles, and submits new drug applications, abbreviated new drug applications and investigational new drug applications to the regulatory agencies.
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Organizes and maintains reporting schedules for new drug application and investigational new drug applications
REQUIREMENTS
- Bachelor or higher degree in pharmacy, or equivalent education
- Minimum of 3 years of working experience within the Pharmaceutical Regulatory environment writing regulatory submissions is preferred
- Pharmacist preferred
- Fluency in written and spoken English; Dutch is an asset
- Expert knowledge, understanding and application of principles, concepts and practices of government regulations are required.
- Expert regulatory knowledge to maintain legal status of products and minimize risk.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.
