Regulatory Affairs Manager
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 and Pharmaceutical organization, based in Netherlands.
A well-known professional Biotechnology and Pharmaceutical international organization, where a subsidiary is placed the Netherlands. As a worldwide leader supplying the pharmaceutical and biotechnology industries with biopharmaceuticals.
The Global RA Department is seeking for Regulatory Affairs Specialist with extensive experience in RA within the Life Sciences Industry.
ROLE DESCRIPTION
As the Regulatory Affairs Specialist you need to provide regulatory information to increase regulatory compliance, make fast and well informed regulatory decision and thereby also manage regulatory risk. The provisions of fast access to accurate information.
RESPONSIBILITIES
- Collaborate with different departments to identify and assess key regulatory requirements, regulations and information;
- Write technical regulatory intelligence reports. Make recommendations based on collected data;
- Evaluate regulatory information for relevance and its impact to the company internal processes;
- 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.
REQUIREMENTS
- Academic degree in scientific or business related discipline;
- Extensive experience in the pharmaceutical and/or biotech industry;
- 3 or more years related in a pharmaceutical / biotechnological related industry in area of regulatory compliance;
- Excellent command of English and Dutch;
- Decision-making ability;
- Skilled writer of technical texts;
- Communication skills.
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.
