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 : Regulatory Affairs (RA) CMC Submission Coordinator
• Responsible for High quality regulatory submissions and operational documentation.
• Perform compliance and operational support including QC checks and compliance/ regulatory database entry and reports
• Create submission documentation such as folders, metadata forms, RA request forms
• Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems.
• Coordinate data/critical metrics required for reports within RA CMC.Perform super-user role of documentation system/ support super-user for e.g. account requests/ modifications as assigned.
• Coordinate, prepare and track CMC submissions for delivery to RA Operations. No delays in approvals of clinical studies, global registration dossiers or variations due to late or inadequate CMC documentation and compliance support on matters within CMC control.
• Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
• Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders
• General qualification for university entrance or completed vocational training ; Science degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Minimum industry experience of 1-2 years in Pharma Industry are preferred
• Prior publishing experience desired
• Excellent communication skills in English required
• Ability to collaborate and work across cross-functional teams
• Effective planning, organizational and interpersonal skills.
• Computer literacy/IT systems literacy: Excellent data processing skills
Experience : 1-2 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Research & Development
End Date : 20th August, 2020
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