Regulatory Affairs Lead – Levant
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Amman • Jordan
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Job Level
About the role
- own regulatory strategy and safety oversight for assigned products and projects
- lead regulatory submissions and approvals- prepare, product registrations and amendments, and respond to health authority queries
- ensure compliance and governance- maintain adherence to global and local regulatory standards, conduct reviews and audits, and manage compliance risks
- oversee pharmacovigilance activities: supervise collection, analysis and reporting of safety data, identify new safety signals and ensure timely regulatory reporting
- collaborate with stakeholders, partner with clinical, safety, commercial and external partners, and act as the company’s regulatory and safety contact for health authorities and policymakers
- monitor regulatory trends and adapt strategy, track regulatory changes, assess impact, and develop approaches to maintain compliance and accelerate approvals
Requirements
- Bachelor degree as a minimum in a life science or medical discipline (e.g., MD, PharmD. Pharmacy)
- 5–7+ years’ experience in regulatory affairs within the multinational pharmaceutical industry
- Proven track record managing regulatory submissions, compliance activities and safety data analysis
- Experience engaging with health authorities and leading cross‑functional regulatory or safety initiatives
- Strong knowledge of global and local regulatory frameworks
- Excellent attention to detail, problem‑solving skills, and the ability to communicate complex regulatory and safety information clearly
- Proficiency in English (written and spoken)
Benefits
- opportunities to learn and develop are all around us
- benefits are designed with your career and life stage in mind
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory submissionsproduct registrationssafety data analysispharmacovigilancecompliance activitiesregulatory reportingregulatory strategyauditsrisk managementhealth authority engagement
Soft Skills
attention to detailproblem-solvingcommunicationcollaborationleadership
Certifications
Bachelor degree in life scienceMDPharmDPharmacy