Manager Job in Maintenance Regulatory Centers at Novartis
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, MRC (Maintenance Regulatory Centers)
• Preparation of regulatory maintenance submissions, variations, renewals and second wave submissions, Modules 2 to 5.
• Effectively handles submission preparation to ensure implementation dates of variations and file availability dates of second wave submissions are met.
• Evaluates proposed changes and provides regulatory input for worldwide regulatory impact.
• 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.
• Ensures that the partner concern process to higher-level management is followed, as applicable.
• Handles deficiency responses and rejections. Provides regulatory consultancy for products and NTO
• Ensures the receipt of accurate product transfers from DRCs and BD Regulatory. Ensures accurate data management.
• Masters and or Ph.D/ Scientific degree, preferably in science (chemistry, pharmacy, biology or equivalent)
• Good written and spoken English.
• At least 8 years of proven experience in the domain of regulatory with an exposure of working in global organization in generics is preferred.
• Sophisticated project management skills
• Well-structured, result oriented, highly self-committed, resilient, flexible, team player
• Ability to provide strategic guidance to the stakeholders
• High level understanding of Regulatory quality, standards and policies
Experience : 8 years
Qualification : Masters and or Ph.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
ID : 311872BR
End Date : 30th March, 2021