Regulatory CMC Manager
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 Medical Devices and Pharmaceutical organization, based in Antwerpen Belgium.
Our client belongs to the most innovative pharmaceutical companies worldwide.
ROLE DESCRIPTION
In the role als Regulatory CMC Manager you are mainly responsible for the authoring of all regulatory CMC dossiers. You provide input and scientific oversight to the Modules 2 and 3 of marketing and clinical trial applications.
This position requires up to 10% international travel.
RESPONSIBILITIES
- Responsible for global marketing authorization and clinical trial submissions
- Main focus on Module 2 and 3 Quality sections
- Ensure that final versions comply with regulatory requirements
- Regulatory risk assessments and recommendations
- Regulatory Guidance
REQUIREMENTS
- Master degree or PhD in Life Science
- Min. 5+ years' relevant industry experience
- Knowledge of both large and small molecule pharmaceutical CMC development
- Good people management and negotiating skills
- Excellent command in English (both written and verbally)
- Proficient in computer applications (MS Office)
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.
