Regulatory Affairs Consultant Safety/Labelling Milano

Regulatory Affairs Consultant Safety/Labelling
Milano
Lombardia, Milano

When our values align, there's no limit to what we can achieve.

Are you an experienced regulatory professional looking for a new opportunity?

We are currently seeking a Regulatory Affairs Consultant - Safety/Labelling to join our dynamic team!

This is a client dedicated project, and the role can be office or home based in various European locations. Key responsibilities will include:Acting as expert for labelling-related activitiesProviding strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and executionDeveloping, supporting and reviewing labelling and/or safety-related contentCreating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labelsAdvising on the regulatory requirements for labelling updates in different global regions e. g.

EU and ROW. Experienced in managing responses to regulatory authoring questions and negotiating company positions with regulatory authoritiesSkills and experience:Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred3-5 years of experience in an industry-related environmentPrevious experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) roleExperience interacting with a regulatory authoritiesCritical thinking and problem-solving skillsProject leadership and management knowledgeExcellent interpersonal and intercultural communication skills, both written and verbal