Our client needs the support of an experienced Regulatory Affairs Consultant working within the US Market and FDA to support two new combination products in the preparation stage for pre-submission, submission, and registration in the US.
Project length: 6 - 12 months project
Project start: November 2022
On-site need: 2-3 days per month
Language requirements: Fluent English other languages would be plus
- Preparation, update, and review of CTD for drug substance
- Support with new combination products registration in US and FDA
- Support and follow-up of the CTD files with health authorities and answers to questions from the health authorities
- Collaboration with other departments: clinical, regulatory affairs - medical device, quality assurance.
* At least 5 years experience within the Pharmaceutical or Medical device industry with at least 2 years experience with combination products
* Strong Experience with CTD files mainly modules 2 and 3
* Experiences with US and FDA drug substances and combination products registration
* Fluent English German, Italian or French would be plus