Pharma Specialist – MRC Job Opening Available @ Novartis
Pharma Specialist – MRC Job. Pharmaceutical Science Jobs. Applications are invited for the post of Safety officer @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis.vacancy at Novartis. Interested candidates may apply online. Check out all the details on Rasayanika.com
Job ID: 270940BR
Position Title: Specialist – MRC
Site: Hyderabad, AP
Eligibility: Masters Degree in Science or Pharmacy with Minimum 5 years of relevant experience in the domain of regulatory with an exposure of working in a global organization in generics is preferred
- Ability to plan and priorities workload
- Advanced project management skills
- Ability to build effective relationships across teams
- Active command in English with excellent written and spoken communication skills
- Good knowledge of Regulatory tools.
- Ability to provide strategic guidance to the stakeholders
- Creative thinking and effective interdisciplinary collaboration with other functions.
Your responsibilities include, but are not limited to:
• 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
• 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 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
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