REQ-10047824
India

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.

About the Role

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 ​

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

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