Novartis Chemistry Specialist Job – Chemistry & Pharma Job
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Job ID 273726BR
Position Title Specialist
Minimum requirements
Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) –
Masters or Bachelors Good written and spoken English. Local language is an advantage
• At least 5 years of relevant experience in the domain of regulatory with an exposure of working in global organization in generics is preferred.
• Exposure towards project management is a plus
• Well-structured, result-oriented, highly self-committed, resilient, flexible, team player
• High operational excellence orientation
Major Accountabilities
• Preparation of regulatory maintenance submissions, variations, renewals and second wave submissions, Modules 2 to 5.
• Supports in submission preparation to ensure implementation dates of variations and file availability dates of second wave submissions are met.
• Implements 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 Regulato
ry, 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 escalation process to next or higher-level management is followed, as applicable.
• Supports in deficiency responses and rejections.
• Supports in the receipt of proper product transfers from DRCs and BD Regulatory.
• Supports regulatory consultancy for products and NTO.
• Ensures proper data management
Key Performance Indicator
KPI’s, as on-time file availability of second wave submissions and variations dispatched to IM&S, deficiency rate, rejection rate, compliance
Job Description
Position Purpose
Implements regulatory maintenance activities and second wave submissions 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 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.
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