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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:
- Maintains regulatory compliant, competitive, and up-to-date core labeling documents for assigned products. The assigned responsibilities should in general be established products of lower complexity.
- Provides labeling input in maintaining core labeling documents and handling HA or CO labeling queries for assigned products.
- Research and understand the labeling topic including reviewing labels across different markets, competitor labels, study information, labeling regulations, etc.
- Contribute to RA activities regarding Novartis safety risk communications/portfolio stewardship activities having labeling impact for their assigned projects/products.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues. -Frequent internal company and external contacts.
- Represents organization on specific projects -Refers to established policies and procedures for guidance. Contributes to some cost center goals and objectives
- Raised the artwork creation/ revision request in specific systems – connect with global artwork team for new aw creation/ revision. Check and ensure approval from all internal/ external stakeholders on the artworks of imported products printed pkg. materials
- Update the document records for all artworks – Update the trackers/ soft records for aws code numbers. approved aws etc. Support local regulatory team for artwork mock ups by creating it in-house
What You’ll bring to the role :
- Bachelor’s Degree + Post-Graduation Diploma in Packaging Technology
- Process management
- Working experience within the pharmaceutical industry
- Technical knowledge 3-4 years relevant experience
- Knowledge of relevant policies Knowledge of relevant tools and systems
- Attention to detail and quality focused
- High level understanding of Regulatory quality, standards and policies
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!
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