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

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