You will work in a high-performing multi-disciplinary Team to ensure submission of Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs), and CTA/ IND related maintenance activities such as amendments, annual safety reporting, Investigator Brochures, end of trial notifications, submission of CSR etc. You will be responsible to provide input into global regulatory strategy for early development compounds.You will contribute to regulatory innovations (e.g. novel therapeutic approaches, indications or endpoints, or any innovative regulatory pathways).
Global Program Regulatory Manager
Global Pharma Company
Are you looking to work in a global growth company where you can make a real difference? Then you are right with us!
BSc or MSc
As per industry
2-4 years of regulatory experience, spanning activities in early development and Phase I-IV, preferably with a strong knowledge and regulatory operational expertise of EU regulatory affairs. Additional knowledge of other regions is an asset.Scientific knowledge and any additional drug development experience in discovery research, CMC, preclinical pharmacology, toxicology, clinical development or other experimentally based discipline, as well as with biologics is an asset.
Englisch: Sehr gut
If you are interested then kindly send your resume to: email@example.com