Senior Regulatory Affairs Specialist
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 Pharmaceutical organization, based in Noord-Brabant Netherlands.
Our client is one of the leading multinational companies in the pharmaceutical industry focussing on the production and marketing of innovative drugs.
ROLE DESCRIPTION
For a 6-months project, our client is looking for a Senior Regulatory Affairs Specialist who support the RA department with the preparation of any regulatory documentation. Your main responsibility is to ensure that the company's products comply with the regulations of government agencies.
RESPONSIBILITIES
- Be aware of international legislation, guidelines and customer practices.
- Management of product licenses and renewals.
- Understanding and evaluation of complex information.
- Working with specialist computer software and resources.
- Writing product labels and patient information leaflets.
- Planning and developing product trials and interpreting trial data.
- Performing and managing regulatory inspections.
- Submission of license and clinical trials applications to authorities to strict deadlines.
- Specify storage, labelling and packaging requirements.
- Contact person for regulatory authorities
- Project Management
REQUIREMENTS
- MSc/ BSc degree or equivalent in a Life Science
- min 6+ years' experience in Pharmaceutical Regulatory Affairs on an international basis.
- Experience within a clinical trial program environment.
- Demonstrate an appreciation and understanding of the positive impact of regulatory in delivering business solutions. (Business Skill-set appreciated)
- Good team management abilities
- Excellent communication skills in English, both verbal and written
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Anja Paetel.
