Find regulatory affairs jobs in Europe for pharmaceutical industry regulators such as EMA, FDA, NICE.
Regulatory Affairs jobs in Belgium (2), Bulgaria (1), Denmark (2), Germany (2), Greece (3), Italy (1), Multiple Countries (3), Netherlands (1), Spain (1), Switzerland (4) and United Kingdom (3).
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.
This key role will be responsible for ensuring the development and delivery of science-based, solution-oriented, and internally aligned regulatory CMC strategies for the program(s) under his/her accountability. Create high quality compliant CMC
Develop and execute robust global regulatory CMC strategies for marketed biological products throughout their lifecycle. Plan, review, and prepare CMC documentation for marketing authorization maintenance, post-approval variations, and health authority
Lead comprehensive post-marketing surveillance activities including proactive monitoring, adverse event trend analysis, signal detection, and signal management for assigned veterinary products, ensuring compliance with global regulatory standards.
It is expected that you will provide regulatory expertise and guidance on European/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal European/ROW regulatory strategy for
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
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