Senior Global Labeling Manager

Job content

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 assigned products should be of higher complexity products and may include developmental programs.

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
  

Minimum Requirements

What you’ll bring to the role:

• Science based degree, advanced degree preferred (MD, PhD PharmD)
• Extensive experience (at least 4-6 years) in global labeling, alternatively extensive experience (5 + years) in related areas of the pharmaceutical industry or Health Authorities
• Experience with new product development and with managing Oncology products
• US and EU Labeling filing experience
• Strong interpersonal, project management, communication, negotiation and problem solving skills
• Ability to lead cross-functional teams in a matrix environment
• Sound understanding of medical and scientific terminologies and good understanding of drug safety information
  

Why consider Novartis?

769 million. That’s how many lives our products touched in 2020. 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!

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

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:

https://talentnetwork.novartis.com/network

Division
Global Drug Development

Business Unit
REG AFFAIRS GDD

Country
Switzerland

Work Location
Basel

Company/Legal Entity

Novartis Pharma AG

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No

Early Talent
No