Job Description

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.Major accountabilities:

• 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 xe2x80x8b

Minimum Requirements:
Work Experience:

• If 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

Skills:

• Being Resilient
• Digital & Technology Savvy
• Continuous Learning
• Interpersonal Savvy
• Operational Excellence
• Project Excellence

Education:

• Minimum: General qualification for university entrance or completed vocational training
• Desirable: Science Degree (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Languages:

• Fluent English required (oral and written). Good written/spoken communication skills

Skills Desired Analytical Skill, Clinical Trials, Collaboration, Detail-Oriented, Lifesciences, Project Planning, Regulatory Compliance