At a Glance
- Tasks: Develop global labelling strategies and maintain core labelling documents for established products.
- Company: Join Novartis, a leader in global health, based in London at The Westworks.
- Benefits: Work from home if living over 50 miles from the London office, with 12 on-site days per month.
- Other info: Mentorship opportunities and involvement in audit readiness initiatives are included.
- Why this job: Contribute to impactful labelling strategies across a diverse portfolio of established products.
- Qualifications: Fluency in English and experience in Global Labelling or Regulatory Affairs required.
The predicted salary is between 60000 - 80000 £ 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.
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) employer: Job Search Place Limited
Novartis is dedicated to creating an inclusive work environment and diverse teams. Located in London, they offer flexible working arrangements and focus on global health initiatives. Join a team committed to continuous improvement and patient representation.
