After an exciting partnership with a clinical-stage biotechnology company that specialize in the discovery and development of small molecule medicines, I am looking for experience, driven professionals to join the company in a Regulatory Associate Lead CMC position.
The growing dynamic biotech have a pipeline compromising of phase 1, phase 2, pre-clinical and discovery studies in cystic fibrosis, inflammation, fibrosis and osteoarthritis, with a core focus on the development and commercialization of novel medicines that will drastically improve lives!
As a Regulatory Associate Lead CMC, you will be responsible for managing the day-to-day support activities to obtain and maintain Regulatory approvals for their products, with a primary focus on CMC submissions.
- Coordinate, prepare, submit, maintain and comply with the quality IMP documentation in clinical trial applications.
- Assist the preparation and compilation of scientific regulatory dossiers and briefing packages.
- Provide Regulatory intelligence
- Assist with the compilation and implementation of defined procedural documents and processes
If you are looking to progress quickly in your career and working within a growing, dynamic company, APPLY NOW!