Novartis
Designation : Submission Co-ordintor RA
Function : RA
Functional Area : Regulatory Affairs
Job Role Summary : Provide regulatory CMC operational, submission and compliance support to department in accordance to defined requirements to guarantee timely preparation of high-quality CMC regulatory submissions and associated compliance information throughout the life cycle.
Job Profile :
- Perform compliance and operational activities including QC check, DA checks and IND annual report writing. CMC contact for some countries and compliance/ regulatory database entry and reports
- Create CMC submission documentation such as folders structure, metadata forms, RA request forms and act as data stewards in the applicable Regulatory Information Management System
- Ensure CMC documentation is eCTD compliant, eCTD filenames assigned, Document formatting (DA) checked, PDF properties are compliant for eCTD submission, documentation is finalized and eCTD file names assigned
- Coordinate data/KPIs required for reports within RA CMC
- Support project teams for document finalization, collate ancillary documents requirements from various sources (e.g. databases, OneNote, trending etc.) and support coordination and management through the appropriate system
- Coordinate, prepare and track CMC submissions for delivery to RA Operations
- Perform super-user role of RA CMC documentation system/ support super-user for e.g. account requests/ modifications as assigned
- Acquire and maintain GMP Certificates and Manufacturing Authorizations required for RA CMC submission in the Document Management System
- Support other GSOC team members for end-to-end submission coordination
Job Requirements :
- Preferably 2 years in regulatory and/or experience in the pharmaceutical industry
- Working experience in pharma industry data systems and data management
Work / Job Experience : 1 Years
Type of Experience : Regulatory and/or experience in the pharmaceutical industry. Working experience in pharma industry data systems and data management
Academic Qualifications :
Minimum: General qualification for university entrance or completed vocational training
Desirable: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
