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.
Responsibilities :
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
Key performance indicators:
High quality regulatory submissions and operational documentation
Timeliness of deliverables: 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 RA CMC control
Timely and accurate information / communication about operational and compliance issues within own department and to key stakeholders
Ensure that the operational activities and CMC regulatory documentation follow Novartis and eCTD guidelines. Regulatory compliance met in all compliance systems
Build and maintain collaborative partnerships with stakeholder
Partner with other GSOC team members to ensure business continuity
Requirements:
General qualification for university entrance or completed vocational training
Desirable: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
University entrance or completed vocational training: Preferably 2 years in regulatory and/or experience in the pharmaceutical industry
If Science Degree: Preferably 1 year in regulatory and/or experience in the pharmaceutical industry
Working experience in pharma industry data systems and data management
Ability to work successfully with global project teams and prioritize activities considering timelines and workload
Effective planning, organizational and interpersonal skills
Prior publishing experience desired
Computer literacy/IT systems literacy: Excellent data processing skills
Fluent English required (oral and written). Good written/spoken communication skills
Skills:
Being Resilient
Digital & Technology Savvy
Continuous Learning
Interpersonal Savvy
Operational Excellence
Project Excellence