Senior Global Labeling Manager

Nov 10, 2021

Job Description

26 major approvals. 13 major submissions. 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease conditionals with unmet needs.

We are expanding our global team and encourage you to consider a career in Regulatory Affairs at Novartis. Working collaboratively and interactively thanks to our technology, we have been as connected as ever—OneRA as we call it. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. Read on to learn what you could do as part of our closely knit team.

The RA Senior Global Labeling Manager (Sr. GLM) is responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date core labeling documents for assigned developmental programs and Novartis Innovative Medicines products. The RA Sr. GLM provides strategic and operational regulatory labeling input and works in close collaboration with Expert Labeling Task Force (ELTF) members in creating or maintaining core labeling documents and handling HA or CO labeling queries for assigned products.

Your responsibilities will include but are not limited to:
• Serve as the labeling lead for all labeling related topics for Novartis products and development projects

• Coordinate and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate

• Lead and/contribute to presentations on labeling related topics for the assigned products at relevant board/forum/committee (e.g., GLC, SMT, MSRB, PSB)

• Contribute to global labeling management and continuous improvement initiatives, review and comment on emerging regulatory labeling guidelines

• Represent GL during audits and inspections

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you'll bring to the role:
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred.

• Minimum 2-3 years’ experience in global labeling or other regulatory affairs functions, alternatively 5 years’ experience in related areas of the pharmaceutical industry, or Health Authorities.

• Strong interpersonal, project management, communication, negotiation and problem solving skills

• Ability to lead cross-functional teams in a matrix environment

• Organizational awareness (interrelationship of departments, business priorities)
Sound understanding of medical and scientific terminologies

• Good understanding of drug safety information

Why consider Novartis?

799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

Imagine what you could do at Novartis!

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Global Drug Development
Research & Development
Full Time
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Senior Global Labeling Manager

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