Novartis
Hiring Regulatory Affairs (RA) CMC Submission Coordinator
Job Description
576! That is the total number of projects and products on our
Global Regulatory Affairs CMC project list. All of these innovative projects
are aimed at making a difference in patients’ lives and we need your help. As
Associate Manager within our Global Regulatory Affairs CMC team, you support
timely preparation of high quality CMC regulatory documentation for our
products and contribute to global regulatory submissions and strategies.
Your 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
What you’ll bring to the role:
• General qualification for university entrance or completed vocational training
Desirable: 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
• General qualification for university entrance or completed vocational training
Desirable: 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
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