Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : Manager, Maintenance Regulatory Centers (MRC)
• Prepares and implements regulatory maintenance activities and second wave submissions – Modules 2-5 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
• Evaluates proposed changes and provides regulatory input for worldwide regulatory impact. Ensures the receipt of proper product transfers from DRCs and BD Regulatory.
• Contributes to performance and KPI´s of the team to deliver agreed targets and objectives and supports reporting.
• Provides DRCs/MRC sites/BD Regulatory, manufacturing business units with proper data and change evaluations to plan and implement registration activities and to meet commitments and requests of deficiency letters.
• Handles deficiency responses, rejection with relevant data management.
• Provides regulatory consultancy for products and NTO
• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) - Masters and or Ph.D
• At least 8 years of relevant experience in the Regulatory Life Cycle Management of Sterile Oncology Injectable products with an exposure of working in global organization in generics is preferred.
• Advanced project management skills
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
• Ability to provide strategic guidance to the stakeholders
• Excellent communication skills
Experience : 5+ years
Qualification : B.Pharm, M.Pharm, M.Sc or Ph.D
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : R&D
End Date : 10th April, 2020
See All Other Jobs in our Database