Regulatory Affairs Regional Program Director - GCC & ME

Organon LLC

Dubai

Remote

AED 320,000 - 520,000

Full time

4 days ago
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Job summary

Organon LLC in Dubai seeks a Regulatory Affairs Regional Project Manager (RAPM) to lead global regulatory change projects across 30-40 countries in EEMEA, ensuring on-time approvals and uninterrupted supply. You will liaison between global sourcing and in-country regulatory leads, work with regional regulatory and CMC teams, drive changes, and deliver solution-oriented outcomes.

Required: 7+ years in regulatory affairs in GCC/Middle East, Bachelor’s or higher in Life Sciences, fluent Arabic and

Qualifications

  • Bachelor’s or advanced degree in Life Sciences or related field.
  • Minimum 7 years in regulatory affairs in GCC/Middle East.
  • Experience with regional/regulatory project rollout.
  • Team leadership experience preferred.

Responsibilities

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

Skills

Regulatory affairs
Project management
Team leadership
Bilingual Arabic/English

Education

Bachelor’s degree in Life Sciences
Advanced degree (MS, MBA, Ph.D., PharmD)

Job description

Organon LLC in Dubai seeks a Regulatory Affairs Regional Project Manager (RAPM) to lead global regulatory change projects across 30-40 countries in EEMEA, ensuring on-time approvals and uninterrupted supply. You will liaison between global sourcing and in-country regulatory leads, work with regional regulatory and CMC teams, drive changes, and deliver solution-oriented outcomes.

Required: 7+ years in regulatory affairs in GCC/Middle East, Bachelor’s or higher in Life Sciences, fluent Arabic and

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