RA Operational Excellence Junior Associate – MEA

Major accountabilities (Under the supervision of OPEX Managers):

I. Excellence in life cycle maintenance activity:

• Support in the preparation of the execution plan with clear KPIs to address the gaps identified in a specific market within MEA Cluster and drive successful implementation of the execution plan with aggressive timelines.
• For specific franchises, prepare and follow up on the mitigation plan implementation related to the site transfer activity within MEA to minimize the financial impact and ensure supply continuity in close collaboration with the MEA Supply chain, Global Teams NTO team and all involved stakeholders.

II. Regulatory Intelligence

• Support the countries in MEA region with preparing for new regulation implementation where there is an impact on the operational excellence activity (e‐CTD/ Base‐ line/ NeeS/ new renewal requirements…)

III. RA compliance management for MEA

• Support in establishing robust processes to meet the regulatory compliance deliverables (onboarding processes/ Local SOP/ PSUR, RMP & Renewal submission as well as tracking and aligning with the relevant stakeholders/ on HA communications about safety tracking/ training curriculum identification/ archiving…)
• Support countries in the proper and timely implementation of the processes once established with a close oversight on a country per country basis.
• Ensure alignment of local working procedures with global processes and monitor the CPO adherence to them.
• Monthly monitoring for compliance reports for the region to identify the gaps and work closely with the CPOs to address it.
• Implement proactive monitoring of key KPIs (variations, renewals…) to ensure compliance.
• Monthly spot checks on Dragon and other internal reporting tools to ensure proper and timely system update.
• Support CPO RA Head and CPO QA for Audit preparations
• Ensure oversight of deviations and related CAPAs. Oversight of out‐of‐compliance cases in RA MEA, tracking of cases, identification of root causes and solutions. Ensure implementation of corrective actions.

IV. Administrative Tasks  

• Schedule Management:  manage schedules, appointments, and travel arrangements.
• Meeting Coordination: Arrange and coordinate meetings, including preparing agendas, taking minutes, and following up on action items.
• Expense Reporting: Prepare, process, and reconcile expense reports, ensuring compliance with company policies.
• Other Administrative tasks.
   

V. Key performance indicators:

• Increased compliance and effectiveness in the life cycle maintenance metrics (site transfers/ renewals/ variations)
• Full readiness for Audit / audit outcomes.
• Compliance KPIs (Dragon/ NP4/ Compliance KPIs (training/ SLC/ audit outcome)
• Organization and accuracy in managing all the administrative tasks.

VI. Minimum Requirements:

• Pharmacist or bachelor's degree in sciences (Chemistry, Biology or any other scientific background)
• A minimum of 1-3 years practical experience in regulatory affairs dealing with a wide variety of registration projects and issues, experience in MEA countries is a plus.
• Fluency in English Language (Arabic and/or French is a plus)
• Effective planning, organizational, and interpersonal skills.
• Good maneuvering in provided IT tools.
• Leveraging off available Artificial Intelligence Tools
• Detail-oriented with a proactive approach to problem-solving.
• Ability to work independently and collaboratively within a team.
• Very good knowledge in navigating through Regulatory systems and analyzing Databases.