RA Operational Excellence and Strategy Head- MEA

Job Description

769 million lives touched by our products. Imagine what you could do at Novartis. No matter where you work, you could contribute to solving some of the toughest healthcare challenges and have an extraordinary impact on people’s lives. Join us!
We are hiring for a Regulatory Affairs (RA) MEA Operational Excellence and Strategy Head who will be responsible for maximizing operational effectiveness of RA MEA, drive productivity and continuous improvement in key business processes while partnering with RA heads, Drive excellence in new launches/new registration planning by proactive risk/benefit assessment while ensuring early engagement with relevant stakeholders and Accountable for OPEX and Labelling department deliverables (shared packs) while maximizing efficiency and compliance. The person will also be responsible for capability building and establishment of regulatory best practices and ensuring quality and regulatory compliance deliverables are met across the MEA countries.
Major Accountabilities of the role:
RA MEA operational excellence management:
• Coach, lead and develop operational excellence and labelling teams.
• Ensure building agile OPEX capabilities to manage crisis situation (resources constraints, backlog clearance, business continuity, or any other factor triggering risk on local business).
• Partner with RA Heads to drive development of working models to support enhanced and robust regulatory processes and compliance status.
• Oversight processes implementation to meet KPIs across MEA (onboarding processes/ Local SOPs/ business continuity/ training curriculum identification/ archiving/ etc.)
• Oversight and monitor the monthly compliance reports for the region and identify the gaps and work closely with the COs to address it.
• Enroll initiatives to improve productivity and resource management (portfolio optimization, resource allocation, capability building, simplification, IT tools, etc.)
• Regular deep dive in country processes as for self-assessment, and work closely with CO RA Heads and CO QA to drive the management of RA related deliverables in preparation of audits or inspections; Support and oversight the development of RA related CAPAs to address audit/inspection findings and Follow Up on timely CAPA closure including regular deviation monitoring.
Excellence in new Launches/ new registration planning:
• In close collaboration with Global and regional RA teams manage the pipeline commu-nication and provide update of the global planning for all new MAA/indications on timely manner to the countries.
• Support countries to prepare robust risk/ops master list, 6-12M ahead of planned submission dates, to proactively plan and execute accelerated registration for the key projects/ pipeline.
• Take initiatives to enroll innovative approaches within the region and create forums to share best practices to further improve access of patients in MEA to our innovative products.
Others: Miscellaneous
• Regulatory intelligence:
Monitor regulatory intelligence for key topics across MEA and Ensure regulatory intelligence is translated into tangible regulatory strategy for NVS in cooperation of the RA in the countries (oversight and assess opportunities for collaboration and synergy between MEA countries as relevant and in alignment with the global position).
• Projects with Financial impact: Monitor RA projects having financial impact on the business, such as but not limited to, site transfer, MAH transfer, acquisition or divestment, renewals, recall or supply shortages, and ensure overall picture is captured and communicated as relevant.

Minimum Requirements

• Pharmacist or B.Sc. (Zoology, Botany & Chemistry)
• 7-10 years practical experience in regulatory affairs dealing with a wide variety of registration projects and geographies (Levant & Gulf experience as basis, plus any additional countries in MEA or emergent markets)
• People coaching and development
• Strategic thinking
• Operational excellence
• Change management 381173BR

RA Operational Excellence and Strategy Head- MEA

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