Regulatory affairs officers new december 24 Jobs in Dublin

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 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