Regulatory Affairs Consultant Safety/Labelling

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 activities Providing strategic labelling guidance and/or input in regulatory impact assessment, submission preparation and execution Developing, supporting and reviewing labelling and/or safety-related content Creating and maintaining the CCDS; leading and coordinating CCDS updates, coordinating and overseeing the implementation of updates into local labels Advising 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 authorities Skills and experience: Minimum of a Bachelor's Degree in a Scientific or Technical Discipline, Advanced Degree Preferred 3-5 years of experience in an industry-related environment Previous experience working in the pharmaceutical industry in support of Global Labelling or in a Regulatory (Clinical / Safety) role Experience interacting with a regulatory authorities Critical thinking and problem-solving skills Project leadership and management knowledge Excellent interpersonal and intercultural communication skills, both written and verbal #LI-REMOTE