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As our new Associate Director RA Device, you will be driving the regulatory strategy for device constituent parts of combination products and use your device regulatory experience...
This role serves as a close business partner and facilitator of regulatory activities and is expected to contribute to developing sound regulatory strategies globally. The role...
Create and Review regulatory documentation for Drug, Device and Combination product renewals with major focus on Medical Device renewals; Track status and progress of regulatory...
Develop and maintain excellent thought leader relationships in the field of rare disease specifically Fabry Disease, Pompe Disease and Batten Disease; Lead on medical initiatives...
Support the analysts with technical input during performance of analytical determinations on active drug substance, raw material, intermediates and final drug product in agreement...
Independently prepare Patient Safety Narratives, Patient Lay Summaries, patient consent forms and dossier related documentation (such as Clinical summaries, Briefing Books, PDCO...