Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager, Maintenance Regulatory Centers (MRC) (Labelling)
• Update core texts SmPCs/PL/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals.
• 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 sharepoints as defined.
• Coordinate and drive independently labelling projects or specific safety tasks as assigned.
• Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
• Acts as a reviewer of labelling documents ensuring that the content complies with regulatory requirements and guidelines.
• Provide technical training as and when essential for effective utilization of employees.
• Represent Global Labelling team in inspections and audits, different boards and projects as well as in associations.
• Mentor less experienced members of the regulatory community.
• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters and or Ph.D. Good written and spoken English. Local language is an advantage
• At least 8 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred
• Experience in managing databases; maintaining sharepoints; with added skills in Excel, is preferred
• Advanced project management skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
• Ability to provide strategic guidance to the stakeholders
Experience : 5+ years
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : R&D
End Date : 20th March, 2020
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