Sr. Global Labeling Manager

Job Description

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects.
We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.

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

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 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.

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

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

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

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to: [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

The pay range for this position at commencement of employment is expected to be between $124,000 and $186,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network