Novartis Biology Regulatory Affairs Job – Biochem & Biotech Apply
Novartis Biology Regulatory Affairs Job – Biochem & Biotech Apply. Biochemistry, Biotechnology, Biology candidates apply online for a Regulatory Affairs (RA) CMC Submission Coordinator position that is available at Novartis. Novartis is hiring MSc candidates, as per the details below in their Research & Development area:
Job Title: Regulatory Affairs (RA) CMC Submission Coordinator
Job ID: 299653BR
Location: Hyderabad, AP
Division: Global Drug Development
Business Unit: REG AFFAIRS GDD
Employment Type: Regular
Responsibilities:
Your responsibilities include but not are limited to:
- 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
Minimum requirements:
- General qualification for university entrance or completed vocational training
Desirable: Science degree (e.g. Biochemistry, Biotechnology, Biology) or equivalent - Minimum industry experience of 1-2 years in Pharma Industry is 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
APPLY ONLINE
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