At a Glance
- Tasks: Lead global labelling strategies and collaborate with cross-functional teams.
- Company: Join Novartis, a leader in healthcare innovation and inclusivity.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Diverse and inclusive workplace committed to continuous improvement.
- Why this job: Make a real impact in global health by shaping labelling strategies.
- Qualifications: Experience in Global Labelling or Regulatory Affairs and strong communication skills.
The predicted salary is between 80000 - 100000 £ per year.
Global Labelling Associate Director, Content (Cardiovascular, Renal & Metabolism) located in London. 12 days on site if within 50 miles of the London office, otherwise remote. Contribute to global labelling strategies across the product portfolio.
Responsibilities
- Develop and maintain global labelling strategies and documents (e.g., CDS, USPI, EU SmPC/PIL).
- Lead cross‑functional discussions to align on labelling content and strategy.
- Present labelling proposals and updates to governance bodies and project teams.
- Identify emerging labelling considerations, contributing to planning, risk assessment, and mitigation strategies.
- Analyse competitor labelling, regulatory guidance, and scientific data to inform content development.
- Support 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 support audit readiness, inspections, and continuous improvement initiatives.
Qualifications
- Fluency in English (written and spoken).
- Demonstrated capability in Global Labelling and/or Global Regulatory Affairs, focused on labelling across development and lifecycle activities.
- Ability to develop and maintain core labelling documents (e.g., CDS) and support major market labelling with scientific accuracy and compliance.
- Ability to interpret clinical efficacy and safety data and translate 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, facilitating cross‑functional discussions and supporting 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 (Cardiovascular, Renal & Metabolism) employer: Novartis UK
At Novartis, we pride ourselves on being an exceptional employer, offering a dynamic work culture that fosters collaboration and innovation in the heart of London. Our commitment to employee growth is evident through mentorship opportunities and continuous improvement initiatives, ensuring that our team members thrive in their careers while contributing to meaningful global labelling strategies in the cardiovascular, renal, and metabolism sectors. With a focus on diversity and inclusion, we create an environment where every voice is valued, making Novartis not just a workplace, but a community dedicated to improving patient outcomes.