Novartis MRC Associate Job Vacancy – Chemistry & Pharma
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Job Title: Associate, Maintenance Regulatory Centers (MRC)
Job Id: 292027BR
Minimum requirements
What you’ll bring to the role:
• Scientific academic degree, preferably in natural science (chemistry, pharmacy, biology or equivalent) – Masters or Bachelors
• At least 2 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
• Excellent communication skills and learning agility
Your responsibilities:
Your responsibilities include, but are not limited to:
• 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.
• Supports in submission preparation to ensure implementation dates of
• 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 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 escalation process to next or higher level management is followed, as applicable.
• Supports in the receipt of proper product transfers from DRCs and BD Regulatory.
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