Novartis MRC Specialist Job Vacancy – Chemistry & Pharma
Novartis BPharma Job B.Pharma Expert job openings. Pharmaceutical Jobs. Applications are invited for the post of Specialist @ Novartis. Career @ Novartis Pharma job opening .vacancy at Novartis. Interested candidates may apply online. Novartis Pharma jobs 2019. Check out all the details and apply online.
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 lifecyclein accordance with Sandoz labelling processes and standards.
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.
Editor’s Note: Novartis MRC Specialist Job Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.