At a Glance
- Tasks: Lead global labelling strategies and create clear, compliant content for established products.
- Company: Join Novartis, a leader in healthcare committed to diversity and inclusion.
- Benefits: Flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement and career development.
- Why this job: Make a real impact on global health by shaping labelling strategies for vital products.
- Qualifications: Experience in Global Labelling or Regulatory Affairs with strong communication skills.
The predicted salary is between 70000 - 90000 £ per year.
We are looking for a Global Labelling Associate Director, Content (Established Products) to contribute to the development and delivery of global labelling strategies across a portfolio of products. In this role, you will support the creation of clear, consistent, and scientifically robust labelling content across development and lifecycle stages.
Responsibilities
- Develop and maintain global labelling strategies and core labelling documents for assigned products (e.g. CDS, USPI, EU SmPC/PIL).
- Lead and facilitate cross functional discussions to support alignment on labelling content and strategy.
- Present labelling proposals and updates to governance bodies and project teams.
- Identify emerging labelling considerations and contribute to planning, risk assessment, and mitigation strategies.
- Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.
- Support and contribute to responses to Health Authority queries and interactions, including preparation of supporting documentation.
- Collaborate with global and regional partners to ensure consistency and alignment across markets.
- Mentor colleagues and contribute to audit readiness, inspections, and continuous improvement initiatives.
Essential Requirements
- Fluency in English (written and spoken).
- Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, with a focus on labelling across development and lifecycle activities.
- Ability to develop and maintain core labelling documents (e.g. CDS) and support major market labelling (e.g. USPI, EU SmPC/PIL) with scientific accuracy and compliance.
- Ability to interpret clinical efficacy and safety data and translate it into clear, consistent labelling content and supporting documentation.
- Working knowledge of global labelling standards and expectations, including major Health Authority requirements.
- Strong collaboration and communication skills, with the ability to facilitate cross functional discussions and support alignment.
- Strong planning, prioritisation, and attention to detail to deliver high quality work within timelines.
Commitment to Diversity and Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Global Labelling Associate Director, Content (Established Products) in London employer: Job Search Place Limited
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation. Our London office provides a flexible working environment, with opportunities for both on-site and remote work, ensuring a healthy work-life balance. We are dedicated to employee growth, providing mentorship and continuous improvement initiatives, making it an ideal place for professionals seeking meaningful and rewarding careers in global labelling and regulatory affairs.
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