The company is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development services.
The company is operating from six sites in Europe. For the company branch based in Gent, Belgium, we are looking for a Principal CMC RA Manager
YOUR KEY ROLE
The company's Dossier Development team brings tailored and timely services to our customers in the very broad sense of regulatory services. We provide support by writing and submitting CMC regulatory documents (e.g. MAAs, IMPDs, variations, etc.) but also scientific reports for diverse customers & projects. As a Principal CMC RA Manager, next to the writing of quality documentation, your key role is also to prepare and execute Global Regulatory CMC strategies, provide guidance to global project teams for (bio)pharmaceutical projects in early development stages, and represent global reg-CMC in projects teams.
YOUR KEY RESPONSIBILITIES
Education and experience: