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Job Discription
1886! We have more than 130 years of experience treating patients. Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide
Your Responsibilities:
Your responsibilities include but not are limited to:
- Update core texts SmPCs/PLs/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals under supervision of a Labelling Manager. Coordinate translations for CPs.
- Ensure in-time hand-over of variation package or response documents to submission teams. Interact with country organizations to ensure timely submission of labelling changes.
- Maintain databases and SharePoint as defined. Technical and administrative support to Labelling Managers and Head of Global Labelling.
- Support regional labelling projects or specific safety tasks.
- Mentor newcomers or less experienced team members as available.
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.
Minimum requirements
What You’ll bring to the role:
Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) – Masters or Bachelors Good written and spoken English. Local language is an advantage
- At least 1 year of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred. Fresh campus graduates with high learning agility can be considered.
- Experience in managing databases; creating and maintaining share points; with added skills in Excel, is preferred.
- Exposure towards project management is a plus.
- Well-structured, result-oriented, highly self-committed, resilient, flexible, team player. High operational excellence orientation.
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world
How will we do this?
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 Sandoz!
Join our Novartis Group 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
SANDOZ
Business Unit
Sandoz Global Development
Country
India
Work Location
Mumbai
Company/Legal Entity
Sdz Pvt Ind
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
Yes
