Senior Regulatory Affairs Consultant (Clinical Writing)

We have a compelling opportunity within client-dedicated regulatory team for a Regulatory Affairs professional with extensive global labeling experience and management of cross-functional teams. This is a senior position open to candidates from different European locations.

Some of the activities Senior Consultant will be responsible for:

Creating / writing Target Label Profiles Coordinating CDS updates Management of cross-functional teams Creating labelling strategies for marketed products and products in the development phase Overseeing system updates Overseeing the development and update of core labelling documents and for tracking implementation at a local and regional level. Qualifications5+ years pharmaceutical/biotechnology industry experience Minimum of 5 years in Regulatory Sciences Experience in supporting regional/ global labelling startegies Prior experience managing cross-functional teams Experience in interpretation of regulations, guidelines, and policy statement Demonstrate excellent communication skills Ability to represent the department in project teams, committees and external meetings Demonstrate strong organizational skills, including the ability to prioritise workload Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff Good knowledge and understanding of applicable regulation BA/BS/University degree required, Life/Health Sciences preferred