Scientific Integrator (Regulatory CMC Dossier Development)
Location: BelgiumSIRE 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.
Our client is a professional Pharmaceutical organisation, based in the area of Brussels. Their goal is to develop and make innovative medicines and ensure that these are available for doctors and patients world wide.
ROLE DESCRIPTION
Drawing on relevant expertise and information from both internal and external sources, make a major contribution towards the preparation of any CMC documentation of specified CMC submissions.
RESPONSIBILITIES
- Drive the Module 2 and 3 quality sections and ensure that they are compliant and fulfill expectations.
- Write global marketing authorization submissions, clinical trial submissions, and respond to health authorities.
- Provide interpretation of relevant CMC guidelines (ICH, FDA, EMA, etc.)
- Provides prompt regulatory risk assessments and recommendations.
- Mentor others in RA guidance.
REQUIREMENTS
- Knowledge of both large molecule and small molecule pharmaceutical CMC development.
- Some years of relevant industry experience (chemical development, pharmaceutical development, analytical development, post-doctoral, graduate course work)
- Demonstrate focus and clarity of thought under ambiguous or complex situations with minimal supervision.
- People management and negotiating skills
- Excellent verbal and written English language skills.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees van Wezel.
