Regulatory Affairs Specialist

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 Biotechnology organization, based in Zuid-Holland Netherlands.

The company is very ambitious and growing pharmaceutical company where there are a lot of opportunities for personal development. Moreover there are a lot of growing possibilities on professional level and personal development.

ROLE DESCRIPTION

The company is searching for a Regulatory Affairs Specialist with extensive experience in RA within the Life Sciences Industry. You will be responsible for several substantive projects.

RESPONSIBILITIES

- Coordination and planning regulatory submissions with management and departments regarding the overall planning to meet customers and project timelines;
- Contribute with regulatory submissions while collaborating with other functions involved. Experience within regulatory submission is a plus;
- Maintain product registration approvals by ensuring compliance with regulatory requirements and be in contact with the health authorities;
- 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;
- Generate a good understanding of the regulatory compliance;
- Contributing to write and review the SOP’s applicable to the RA department

REQUIREMENTS

- Minimum bachelor degree in life science related field,
- Minimum of 3 years of experience in the regulatory affairs in the pharmaceutical industry,
- Experience and knowledge in the pharmaceutical industry,
- Experience with compiling regulatory documents in eCTD or Nees is a plus,
- Excellent communication and writing skills in Dutch and English,
- Good technical writing 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.