Novartis MRC Specialist Job Vacancy - Chemistry & Pharma

Novartis MRC Specialist Job Vacancy – Chemistry & Pharma

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Job ID 289826BR

Position Title Specialist, MRC (Maintenance Regulatory Centers) (Labelling)

Eligibility for Specialist MRC : 

• 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 4 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; creating and maintaining sharepoints; 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 skills are required to be successful in this role.

Job Description for Specialist MRC:

The Specialist is responsible for the maintenance of regulatory compliant, competitive, and up to date core labelling documents for assigned products throughout the product lifecycle

in accordance with Sandoz labelling processes and standards.

Your responsibilities:
Your responsibilities include, but are not limited to:
• Update core texts SmPCs/PLs/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 labelling projects or specific safety tasks as assigned.
• Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.
• Technical and administrative support to Global Labelling Managers and Head of Global Labelling.

Apply Online

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