As the Submission Production Capability Lead, you’ll help shape the strategic vision of Regulatory Affairs and drive its digitalisation by overseeing key products that enable the creation, validation, and electronic delivery of regulatory submissions
Job Summary
As the Submission Production Capability Lead, you’ll help shape the strategic vision of Regulatory Affairs and drive its digitalisation by overseeing key products that enable the creation, validation, and electronic delivery of regulatory submissions.
You will ensure seamless submission production, structured data transfers, and gateway connectivity, while leading a strategy that delivers business value and promotes harmonisation, innovation, and continuous improvement.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Matching Summary
As the Submission Production Capability Lead, you’ll help shape the strategic vision of Regulatory Affairs and drive its digitalisation by overseeing key products that enable the creation, validation, and electronic delivery of regulatory submissions.
Skills & Requirements
Must-have
Submission Production Capability
Regulatory Affairs data and technology
strategic vision for Regulatory Affairs
electronic delivery of regulatory submissions
structured data transfers
gateway connectivity
Nice-to-have
harmonisation, innovation, and continuous improvement
digital governance boards
external digital networks
Commitment to Diversity and Inclusion
Key Requirements
Relevant industry experience
Experience presenting/speaking at senior management level
Demonstrated leadership skills
Strong negotiation skills
Experience with Submission Production processes, systems & tools