Global Labelling Associate Director, Content (CR&M)

Novartis Ireland; Dublin; Hybrid; EUR 75,880 - 140,920; Full time

Benefits offered by this job

Hybrid working options

14 weeks parental leave

Insurance plans

Retirement plans

Car allowance

Job summary

Novartis Ireland is seeking a Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism) to lead the development of high-quality global labelling content across development and lifecycle stages. This role shapes critical product information, ensuring patient safety, regulatory compliance, and commercial success through collaboration with global experts.

Based in Dublin with flexible hybrid options, the position involves leading multidisciplinary teams, presenting to

Qualifications

• Degree in a scientific discipline with regulatory understanding.
• Experience developing global labelling content across the product lifecycle.
• Ability to translate clinical efficacy and safety data into clear labelling content.
• Strong knowledge of global labelling regulations across major health authorities.
• Proven ability to collaborate across multidisciplinary teams and influence stakeholders.

Responsibilities

• Develop and maintain global labelling strategies and content for established products across development and lifecycle activities.
• Lead cross-functional discussions to align on global labelling strategy, content, and product claims.
• Drive creation and maintenance of core and major market labelling documents.
• Present labelling recommendations and strategic proposals to governance bodies and project teams.
• Anticipate emerging labelling risks and develop mitigation, escalation, and contingency plans.
• Support health authority interactions by preparing evidence-based responses and negotiation strategies.
• Mentor colleagues and contribute to continuous improvement and inspection readiness.

Skills

Labelling content

Regulatory knowledge

Cross-functional collaboration

Data interpretation

Attention to detail

Education

Degree in scientific discipline

Job description

Novartis Ireland is seeking a Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism) to lead the development of high-quality global labelling content across development and lifecycle stages. This role shapes critical product information, ensuring patient safety, regulatory compliance, and commercial success through collaboration with global experts.

Based in Dublin with flexible hybrid options, the position involves leading multidisciplinary teams, presenting to