RA Consultant - Work Remotely
Location: SwitzerlandSIRE 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, Chemicals and Pharmaceutical organization, based in Basel-Landschaft Switzerland.
The company is developing and producing APIs/ Peptides for the pharma and biotech industry. They are located in the US, Europe and Switzerland.
ROLE DESCRIPTION
* Work Remotely
* Work independently without supervision
* Availability: from 50% - 100%
* Duration: Flexible. This company develops a long-term recruitment relationship that can lasts years
* Starting date: asap, but it is negotiable depending on availability
The Regulatory Affairs Consultant will help with the work load mainly focussing on DMF files (ASMF, US Type II DMF), compilation and publishing.
RESPONSIBILITIES
- Writing DMF files (ASMF, US Type II DMF)
- Compilation, publishing and submission of the regulatory dossier to the Authorities (EU and US)
- Update of CMC documentation
- Change Control
- Development of Regulatory Strategies
REQUIREMENTS
- Native German
- Strong background in Chemistry (Master or PhD)
- Ideally, experience with APIs/ Peptides
- Excellent scientific writing skills
- Knowledge of GMP
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Patricia Oses Equiza.
