Regional Regulatory Affairs Program Manager (Global)

Organon; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Organon is seeking a Regulatory Affairs Regional Project Manager (RAPM) to lead complex global regulatory change programs across 30-40 countries in the EEMEA region. You will liaise with global sourcing teams and in-country leads to ensure on-time approvals while protecting supply to patients.

Candidate will bring 7+ years of regulatory affairs experience, strong cross-functional skills, and fluency in Arabic and English. Relocation is international and visa sponsorship is provided.

Qualifications

• Regulatory affairs experience with global scope.

Responsibilities

• Manage global regulatory change projects across 30-40 countries in the EEMEA region.
• Coordinate with global sourcing management and in-country regulatory leads.
• Drive change, plan and track submissions and risk mitigation.
• Escalate risks and optimize distribution plans.
• Track HA submissions and authorizations.

Skills

Regulatory planning

Cross-functional leadership

Arabic language

English language

Project management

Stakeholder management

Education

Bachelor’s degree in Life Sciences

Advanced degree in Life Sciences

Job description

Organon is seeking a Regulatory Affairs Regional Project Manager (RAPM) to lead complex global regulatory change programs across 30-40 countries in the EEMEA region. You will liaise with global sourcing teams and in-country leads to ensure on-time approvals while protecting supply to patients.

Candidate will bring 7+ years of regulatory affairs experience, strong cross-functional skills, and fluency in Arabic and English. Relocation is international and visa sponsorship is provided.