REQ-10020301
Αυγ 28, 2024
United Kingdom

Περίληψη

Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people’s lives.   To do this, we are optimizing and strengthening our processes and ways of working.  We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster. We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to. Apply today and welcome to where we thrive together! The role: This role offers hybrid working, requiring 3 days per week in our London office. As Global Labelling Manager (GLM) you will be responsible for the creation and maintenance of regulatory compliant, competitive, and up-to-date core labelling documents for assigned developmental programs and Novartis Innovative Medicines products. The assigned products will be for complex products and may include developmental programs. The RA GLM also provides strategic and operational regulatory labeling input, working in close collaboration with Expert Labeling Task Force (ELTF) members in creating or maintaining core labeling documents. You will also handle Health Authority or Country Operations labeling queries for assigned products.

About the Role

Major accountabilities:

  • You will maintain regulatory compliant, competitive and up-to-date global labelling documents for assigned products, presenting to the Global Labelling Committee on core data sheet changes. 

  • You will coordinate and lead the ELTF to agree labelling strategy, labelling course of action and text. 

  • You will also represent global labelling in relevant sub-teams, research and understand labelling topics across different markets, the competition and regulations. 

  • You will contribute to the creation of high-quality documents for Health Authorities and interact with Country Organisations to ensure the timely implementation of labelling changes in local product information. 

Your experience: 

  • Bachelors or advanced life science degree. 

  • Experience in global labelling, or in related areas of the pharmaceutical industry or Health Authorities.  

  • Strong interpersonal, project management, communication and negotiation skills. 

  • Ability to lead cross functional teams in a complex work environment. 

  • Fluency in English 

Why NovartisHelping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future  together? : https://www.novartis.com/about/strategy/people-and-culture 

 

Commitment to Diversity & Inclusion: 

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

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Development
Innovative Medicines
United Kingdom
London (The Westworks)
Research & Development
Full time
Regular
No

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

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10020301

Reg Affairs Manager Labeling

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