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 : Specialist - IM&S
1. Support regulatory teams during the submission process in all administrative and technical steps according to global procedures
2. Prepare and dispatch/submit documentation packages for predefined submission types and region(s) in compliance with Health Authority requirements
3. Ensure eCTD lifecycle maintenance according to ICH and regional specifications
4. Ensure timely update of submission data in the regulatory information management data-bases and verify that the data is kept compliant
5. Be involved in the timely and efficient processing of regulatory, submission-relevant docu-ments like M1, eApplication Form, COPPs, GMP Certificates
6. Maintain communication network with regulatory functions like RCCs, MRCc and country organizations and non-regulatory stakeholders according to guidance documents
7. Ensure escalation procedures are followed in case of issues and delays
8. Might be involved in document preparation activities like scanning, bookmarking, linking and other activities to ensue document submission readiness
9. Might be involved in document bulk upload activities
1. Masters Degree in Science or Pharmacy with Minimum 2 years to 5 years of relevant experience in Regulatory submission publishing.
2. Ability to plan and priorities workload
3. Ability to work in a matrix environment
4. Ability to build effective relationships across teams
5. Active command in English with excellent written and spoken communication skills
6. Good knowledge of Regulatory tools.
7. Creative thinking and effective interdisciplinary collaboration with other functions.
Experience : 2-5 years
Qualification : M.Sc or M.Pharm
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D
End Date : 10th July, 2019
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