This company is a leading contract development organization for the pharmaceutical industry. They assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinics and market. They provide a comprehensive and integrated portfolio of drug substance and drug product development services.
You will be responsible for writing and submitting regulatory documents (e.g. MAAs, IMPDs, Variations, etc.) and scientific reports for diverse projects. You will manage the life cycle of the drug product from the preparation and submission of the dossier towards the European and American authorities; to the launch of the registered drug on the market, as well as preparation of post-approval variations.
Your main goal is to ensure full compliance with regulatory requirements. To do so, you have a passion for (technical/scientific) writing and the drive to generate qualitative reports and dossiers in collaboration with the dossier development team.
The key responsibilities of the role