The First Line Leader is accountable for developing and enabling a frontline team of operators to consistently deliver exceptional safety, quality, service and cost‑effective products.
The Manager - IT CSV is responsible for end-to-end oversight of Computerized System Validation, equipmen/ utility qualifications, audit support, and quality systems compliance in a GxP-regulated pharmaceutical environment.
Program Manager- R&D Transformation & Productivity, you will play a key role in supporting the execution of strategic transformation initiatives across the global R&D organization. Dr. Reddys Laboratories
Support Medical Affairs objectives for assigned Cardio-Diabetes / Specialty therapies in emerging markets. Provide scientific and clinical inputs using current guidelines, clinical data, and real-world evidence.
Contribute to preparation and delivery of regulatory submissions from a global and regional perspective. Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
Adequate understanding on respective authority guidance and filing of new product and post approval changes. Review of documents related to product registration and dossier submission leading to faster approval
Responsible for one or several of the following: processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information
Emcure is fast-growing Indian pharmaceutical company engaged in developing, manufacturing, and marketing a broad range of pharmaceutical products globally
Candidates must have experience in analysis of raw material, finished product and Stability. Should have hands on experience on HPLC (Chromeleon), GC etc.