Jobs in Switzerland in Clinical Research (11), Data, Programming and Statistics (4), Manufacturing and Logistics (10), Medical (3), Medical Devices (1), Pre-clinical Research and Development (14), Quality Assurance (3) and Sales, Marketing and Communications (1).
Anticipates scientific and technological developments in the field of microbial DSP and drives the implementation of innovative technologies. Ensures high-quality documentation, including experimental plans, reports, risk assessments and technical
The Global Regulatory CMC Lead develops and executes global regulatory CMC strategy for assigned Sobi assets in development, prepares CMC sections of IND/IMPD, MAA, NDA/BLA as well as assesses global filing strategy for post approval changes.
In this role, you will provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs. You will be responsible for quality oversight, process
You will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position
Lead the development of new chemical entities with a focus on Drug Substance matters. Lead manufacturing and scale-up activities toward API including supplies of building blocks, Regulatory starting materials or GMP intermediates
Own the end-to-end lifecycle of Pharmacovigilance Agreements (PVAs), including development, execution, maintenance, and termination where applicable, along with all associated deliverables. Contribute to strategy setting in collaboration with line
This role will be responsible for driving the management of our TTR amyloidosis franchise. This role will support and challenge country teams in tailoring the global strategy to the regional and local market specifics while maintaining global alignment;