Senior Regulatory Affairs Officer

About the role

The Senior Regulatory Affairs Officer will own end‑to‑end regulatory compliance for JPHCo products and support the Pharmacovigilance system under the QPPV. The role covers CTD/eCTD submissions, lifecycle management, liaison with JFDA and regional health authorities, and coordination of PV deliverables.

Key responsibilities

• Plan and execute registration strategies, compile and submit CTD/eCTD Modules 1‑5, and manage version control and archives.
• Handle renewals, variations, labeling/artwork updates, and health authority commitments.
• Lead daily interactions with JFDA and other HAs, responding to queries and deficiencies promptly.
• Track regulatory intelligence (JFDA, WHO, EMA) and drive impact assessments.
• Maintain inspection and audit readiness across all submissions.
• Support PV activities: maintain RA inputs to the PSMF, coordinate PSUR/PBRER sections, update RMPs, prepare safety variations and DHPC packages, and ensure timely escalation of safety information.

Required profile

• Bachelor’s or Master’s in Pharmacy or related field.
• 5‑7 years of regulatory affairs experience in pharmaceutical manufacturing with hands‑on CTD/eCTD work.
• Strong knowledge of JFDA requirements and familiarity with ICH E2 series, GVP‑Arab, and WHO PV guidance.
• Fluent in Arabic and English (spoken and written).
• Valid driver’s license, personal car, and ability to travel within Jordan.

Required skills

• CTD/eCTD preparation and submission.
• PSUR and PBRER compilation.
• Risk Management Plan (RMP) updates.
• Safety variations and DHPC preparation.
• Regulatory intelligence monitoring (JFDA, WHO, EMA).
• Knowledge of ICH E2, GVP‑Arab, WHO PV guidelines.
• Basic ICSR handling, CIOMS and MedDRA literacy.