Clinical Regulatory Manager
Location: GermanySIRE 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 and Pharmaceutical organization, based in Bayern Germany.
Our client is a Pharmaceutical company with their offices in Bavaria
ROLE DESCRIPTION
Guidance of strategic development partners to ensure that external development teams provide appropriate and reliable data.
RESPONSIBILITIES
- Ensure that biowaiver, bioequivalence and clinical parts delivered are appropriate
- Identification of deficiencies in such dossiers and clinical data
- Communicate clinical risks related to developed product to ensure readiness for launch
- Develop clinical development strategies for projects and evaluate cost and timelines for such projects
- Due diligence of external partners on clinical capabilities
- Ensure quality compliance with GCP and Clinical regulatory requirements
- Interdepartmental role communicating with internal and external stakeholders such as customers, regulatory and quality departments
- Timely respond to module 4 and module 5 questions
REQUIREMENTS
- Life Science Degree
- Fluency in English
- At least 3 years of experience in Clinical Research
- Knowledge on Clinical studies
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.
