Remote Regulatory Affairs Director Global Change Programs

Organon GCC; Dubai; Remote; AED 500,000 - 800,000; Full time

Job summary

Organon GCC is seeking a Regulatory Affairs Regional Project Manager to lead global regulatory change projects across 30‑40 countries in the EEMEA region, ensuring on‑time approvals and uninterrupted supply. You will liaise between global sourcing and in-country regulatory leads, driving change with a solution‑oriented approach.

You will manage a team, coordinate with regulatory and CMC colleagues, and uphold risk mitigation and timely communications.

Qualifications

• Bachelor’s degree or higher in life/medical sciences.
• Minimum 7 years in regulatory affairs in GCC/Middle East.
• Experience leading 4–5 direct reports.
• Fluent Arabic and English (written and spoken).
• Strong communication, structured and process‑oriented.

Responsibilities

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

Skills

Regulatory affairs

Project management

Arabic & English

Leadership

Education

Bachelor’s or higher in Life Sciences

Job description

Organon GCC is seeking a Regulatory Affairs Regional Project Manager to lead global regulatory change projects across 30‑40 countries in the EEMEA region, ensuring on‑time approvals and uninterrupted supply. You will liaise between global sourcing and in-country regulatory leads, driving change with a solution‑oriented approach.

You will manage a team, coordinate with regulatory and CMC colleagues, and uphold risk mitigation and timely communications.