Regulatory Affairs Consultant

SIRE 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 Pharmaceutical organization, based in Brussel Belgium.

A well-known professional Pharmaceutical international organization, where a subsidiary is placed in the region of Antwerpen. As a worldwide leader supplying the pharmaceutical industries and in the ongoing process of improving human health.

ROLE DESCRIPTION

The Global RA Department is seeking for Regulatory Affairs contracter with experience in RA submissions to start in a project.

RESPONSIBILITIES

- Responsible for planning, reviewing and coordination of submissions activities for EMEA
- Collaborate with different departments to identify and assess key regulatory requirements, regulations and information
- Experience working with the eCTD and NeeS format
- Analyze and monitor external regulatory environment, including guidance and regulations from regulatory authorities
- Up to date knowledge of regulation and trends to determine and supply for guidance as needed
- Ability to develop and contribute regulatory strategy
- Manage interactions with EU regulatory authorities

REQUIREMENTS

- Academic degree in scientific or business related discipline;
- Extensive experience in the pharmaceutical and/or biotech industry
- 2 or more years related in a pharmaceutical / biotechnological related industry in area of regulatory compliance;
- Excellent written and verbal communication in English, other languages are an asset
- Project management

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.