Job Description:
Major Accountabilities:
- Update core texts SmPCs/PLs/Labelling for EU registration procedures MRP/DCP/CP in English for variations and renewals.
- Coordinate translations for CPs and ensure timely handover of variation packages or response documents to submission teams.
- Interact with country organizations to facilitate timely submission of labeling changes.
- Review and comment on internal or external guidelines and regulations related to regulatory, safety, and legal matters.
- Provide support to Global Labeling Managers on CDS compilation, safety label update evaluation, and document authoring.
- Ensure patient safety through timely and adequate QC reviews for all CDS updates/periodic regular reviews/first version and CDS re-installation of core safety information of marketed products.
- Check signals in the signal management tracking system (cdsDB) and maintain databases and SharePoint sites as defined within the Global Labeling Team.
- Support Compliance Managers in SOP management, PSMF annex preparation, deviations, audits/inspections, and oversee training matrix.
- Coordinate labeling projects or specific safety tasks as assigned and mentor new or less experienced team members as needed.
- Provide technical and administrative support to Global Labeling Managers and Head of Global Labeling.
Key Performance Indicators:
- Timely management of core labeling documents/CDS for assigned products.
- Ensure compliance with Novartis policies and adherence to regulatory internal processes.
- Minimize labeling-related litigation/reputation risks by avoiding unjustified local deviations.
- Provide high-quality regulatory input.
- Performance assessed based on objectives, KPIs, and stakeholder feedback.
Minimum Requirements:
- 3-4 years of relevant experience in Regulatory/Pharmacovigilance domain, preferably in a global organization in generics.
- Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology, or equivalent) – Masters or Bachelors.
Work Experience:
- Cross-Cultural Experience.
- Functional Breadth.
- Collaborating across boundaries.
Skills:
- Detail-Oriented.
- Labeling Documentation.
- Labeling Regulations.
- Operational Excellence.
- Regulatory Compliance.
- Safety.
Languages:
- English.
Desired Skills:
- Detail-Oriented.
- Labeling Documentation.
- Labeling Regulations.
- Operational Excellence.
- Regulatory Compliance.
- Safety.
