Term állások, munkák törzskönyvezés kategóriában

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

• Planning, writing, reviewing and submitting manuscripts on clinical drug trials in humans for peer-reviewed journals and abstracts for scientific conferences
• Data visualization of data from clinical drug trials
• Supporting preparation of posters and conference presentations

Scientific oversight and coordination of preclinical and toxicology studies conducted in collaboration with CROs, academic partners, and scientific institutions - covering both GLP-regulated and exploratory/non‑GLP research...

Lead Expert Quality Assurance, Deputy Responsible Person 40%Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...