200+ projects in development. 20 major approvals. Novartis is looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide.
Your responsibilities include but not are limited to:
•Maintain regulatory compliant, competitive and up to date global labeling documents (Core data sheet (CDS), Basic Patient leaflet (BPL), Basic Succinct Statement (BSS) for assigned products.
Present to GLC on CDS changes.
•Review and release corresponding International Package Leaflets (IPL) for assigned products.
Organize and lead the ELTF to discuss labeling strategy and reach consensus on labeling course of action and labeling text as appropriate.
•Represent GL as a core member of RA Sub-teams, and Safety Management Teams (SMTs) for assigned projects/products. Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
•Contribute to the creation of high quality documents supporting changes to the CDS and responses to labeling-related Health Authority queries Interact with COs to ensure timely implementation of global labeling changes in local product information, and ensure international consistency and compliance with the CDS.
•Contribute to RA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products. Contribute to meeting materials for the assigned products at relevant board/forum/committee (e.g., MSRB, PSB).
•Prepare and review PSUR RA input including their own and other GL associates assigned products. Create and/or maintain International Package Leaflets including their own and other GL associates assigned products.
•The AGLM may also provide labeling support for more senior GL managers as appropriate. Mentor newcomers and less experienced GLMs. Contribute to global labeling management and continuous improvement initiatives.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What You’ll bring to the role:
• Minimum 5-7 years’ experience in global labeling or other other regulatory affairs functions, alternatively up to 4 years’ experience in related areas of the pharmaceutical industry, related industries/academia.
• Strong interpersonal, project management, communication, negotiation and problem solving skills. Fluency in English as business language, additional languages advantageous.
• 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
• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (Masters in Life Sciences or Pharmacy, PhD, PharmD) preferred.
Why consider Novartis?
769 million lives were touched by Novartis medicines in 2020, 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
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