As a Global Labeling Specialist, you’ll play a vital role in providing labeling/artwork strategy, regulatory intelligence, and knowledge necessary for product development, marketing, and maintenance. Your responsibilities will include offering strategic labeling input and support for global development projects and marketed products, ensuring labeling changes are consistent with data and applications, and collaborating with regulatory agencies on product approvals.
Position Name:
Associate – Regulatory Operations
Organization: Sandoz
Qualification: B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences
Experience: 3-4 years
Salary: 35,000-55,000 /month
Location: Hyderabad
Job description:
•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
Apply Now
Link: https://pharmabharat.com/sandoz-hiring-in-regulatory-affairs/
