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.
Prepares and implements regulatory maintenance activities and second wave submissions to achieve targets and business objectives in accordance with the submission plan to avoid stock-outs and delayed launches. Ensures that preparation of variations follow established processes and timelines. Acts as strong business partner and project team member for maintenance/compliance matters. Builds strong interface between the local functions (NTO/ESO/QA) as well as all Sandoz development/maintenance centers to ensure continuous compliance with legal, scientific (technological), ethical and administrative requirements.
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. 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.
•Review and comment on internal or external guidelines and regulations on regulatory, safety and legal topics.Support to Global Labelling Managers on CDS compilation, safety label update evaluation and authoring of documents.
•Ensures patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of the core safety information of marketed products.
•Checks signals in the signal management tracking system (cdsDB), including reference product information and regulatory authority communication for review of CDS and related Expert Statements.
•Screen and maintain databases and sharepoint sites as defined within the Global Labelling Team. Supports Compliance Managers in SOP management, PSMF annex preparation, deviations, Audits/Inspections and oversee training matrix.
•Coordinate labelling projects or specific safety tasks as assigned.As needed, mentors new or less experienced team members on regulatory submissions or safety label update evaluation.Technical and administrative support to Global Labelling Managers and Head of Global Labelling.
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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 4-5 years of relevant experience in Regulatory/Pharmacovigilance domain with an exposure of working in a 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
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Imagine what you could do at Sandoz!
Commitment to Diversity & Inclusion:
Sandoz, a Novartis company, 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 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