Regional Regulatory Project Leader – Global Change (EEMEA)

Organon GCC; Dubai; On-site; AED 514,000 - 698,000; Full time

Job summary

Organon GCC in Dubai is seeking a Regulatory Affairs Regional Project Manager to oversee global regulatory change programs across 30-40 countries in the EEMEA region, ensuring on-time approvals and uninterrupted supply to patients. You will liaise between the global sourcing team and in-country regulatory leads, driving cross-functional improvements with the regulatory and CMC teams.

This role requires 7+ years in regulatory affairs in GCC/Middle East, a Life Sciences degree, and fluency in

Qualifications

• Bachelor’s degree or Advanced degree in Life Sciences, Medical Sciences, Pharmacy.
• 7+ years in regulatory affairs within GCC or Middle East, with complex regional projects.

Responsibilities

• Change management.
• Plan and track on-time initial submissions and RTQs (assume filling plan complete).
• Escalate shifts from the plan and bundling opportunities.
• Identify and elevate any identified risk.
• Communicate and action risk mitigation (e.g. stock plans, re-distribution).
• Track Health Authority submission and authorizations.

Skills

Regulatory affairs

Project management

Arabic & English fluency

Communication

Teamwork

Education

Bachelor’s degree in Life Sciences/Pharmacy

Advanced degree (MS/MBA/Ph.D./PharmD)

Job description

Organon GCC in Dubai is seeking a Regulatory Affairs Regional Project Manager to oversee global regulatory change programs across 30-40 countries in the EEMEA region, ensuring on-time approvals and uninterrupted supply to patients. You will liaise between the global sourcing team and in-country regulatory leads, driving cross-functional improvements with the regulatory and CMC teams.

This role requires 7+ years in regulatory affairs in GCC/Middle East, a Life Sciences degree, and fluency in