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You'll be the primary regulatory CMC voice on cross-functional matrix teams, covering everything from early clinical trial applications through to new marketing authorizations, post-approval changes, and full lifecycle management. That means you won't
You will serve as the Pediatric Regulatory Lead for assigned products and play a key role in developing and executing regulatory strategies, plans, and objectives for pediatric development programmes across the Virology, Oncology, and Inflammation
A key focus area of the position is the preparation of regulatory CMC documentation for small molecule products during development and commercial stage, in a manner that is scientifically sound, commercially viable and in accordance with current
The Senior GVP QA Manager is responsible for supporting the maintenance and continuous improvement of the global Pharmacovigilance (PV) System to ensure that Santhera fulfils its legal PV obligations as both a Marketing Authorisation Holder (MAH) and
Serve as a clinical and scientific subject-matter expert for the assigned therapeutic area and disease indication, with a strong focus on protocol execution and data integrity. Contribute to medical monitoring activities and support ongoing assessment of