Regulatory Affairs Officer (with Pharmacovigilance responsibilities)
Location: Mix of Amman & Al-Mawggar, Jordan
Type: Full-time
Industry: Pharmaceutical Manufacturing
Reports to: General Manager (functional dotted line to QPPV)
About JPHCo
Jordan Pharmaceutical Health Company (JPHCo) develops and manufactures high-quality, safe, and effective pharmaceutical products for Jordan and the region, operating to international GMP and regulatory standards.
Role Summary
Own end-to-end regulatory compliance and timely approvals for JPHCo products and support the Pharmacovigilance (PV) system under the QPPV. Scope includes CTD/eCTD submissions, lifecycle management (variations/renewals), JFDA & regional HA liaison, and coordination of PV deliverables (PSUR/PBRER inputs, RMP updates, safety variations, and DHPC).
Key Responsibilities
- Regulatory Affairs:
- Plan and execute registration strategies and submission roadmaps (generic/biowaiver/BE).
- Compile, author, and submit CTD/eCTD Modules 1–5; control versions and archives.
- Manage renewals, variations, labeling/artwork updates, and HA commitments.
- Lead day-to-day interactions with JFDA/other HAs; respond to queries/deficiencies on time.
- Track regulatory intelligence (JFDA/WHO/EMA); drive impact assessments and implementation.
- Maintain inspection/audit readiness across submissions and correspondence.
- Pharmacovigilance (supporting QPPV):
- Maintain RA inputs to the PSMF; adhere to PV SOPs (ICSR, PSUR, RMP, signal management, safety communication).
- Ensure day-zero escalation of any safety info received by RA; coordinate follow-ups and documentation.
- Coordinate RA sections for PSUR/PBRER and ensure label consistency (SmPC/PIL).
- Support RMP updates and additional risk-minimization measures; prepare safety variations & DHPC packages and archive approvals/dissemination proofs.
- Monitor HA safety circulars/literature alerts; escalate to QPPV within defined timelines.
- Complete PV training; support PV/RA KPIs, audits, and CAPA closure.
Qualifications
- Bachelor’s or Master’s in Pharmacy or related field.
- 5–7 years in Regulatory Affairs within pharmaceutical manufacturing; hands-on CTD/eCTD experience.
- Strong knowledge of JFDA requirements; familiarity with ICH E2 series / GVP-Arab / WHO PV guidance.
- Practical exposure to PSUR/PBRER, RMP, safety variations, DHPC, and ICSR basics (CIOMS/MedDRA literacy a plus).
- Strong CMC/labeling understanding; rigorous document control and follow-through.
- Languages: Arabic & English — fluent (spoken and written), both mandatory.
- Mobility: Valid driver’s license and personal car (required); able to travel within Jordan (and occasionally regionally).
- Preferred: Experience within a local (Jordan-based) pharmaceutical manufacturer operating under GMP, with direct involvement in JFDA submissions and on-site regulatory/GxP workflows.
How to Apply
Send your CV and a brief cover letter to talent.jph@outlook.com with subject: “Regulatory Affairs Officer – [Your Name]”.
JPHCo is an equal-opportunity employer and values diversity.
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