Pharma & Chemistry Specialist – IM&S Job Opening @ Novartis
Pharmaceutical Science Specialist. Applications are invited for the post of Specialist @ Novartis.Career @ Novartis. Pharma job opportunity at Novartis. IM&S vacancy. Interested candidates may apply online. Check out all the details on the same below:
Job Id: 270433BR
Job Title: Specialist – IM&S
Eligibility: Masters Degree in Science or Pharmacy with Minimum 2 years to 5 years of relevant experience in Regulatory submission publishing.
- Ability to plan and priorities workload
- Ability to work in a matrix environment
- Ability to build effective relationships across teams
- Active command in English with excellent written and spoken communication skills
- Good knowledge of Regulatory tools.
- Creative thinking and effective interdisciplinary collaboration with other functions.
Your responsibilities include, but are not limited to:
- Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
- Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
- Ensure eCTD lifecycle maintenance according to ICH and regional specifications
- Ensure timely update of submission data in the regulatory information management databases and verify that the data is kept compliant
- Be involved in the timely and efficient processing of regulatory, submission-relevant documents like M1, Application Form, COPPs, GMP Certificates
- Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents
- Ensure escalation procedures are followed in case of issues and delays
- Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness
- Might be involved in document bulk upload activities
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