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Regulatory Affairs Officer
Annora Pharma FZ-LLC
Dubai, UAE
Full Time
Mid
Today
Regulatory AffairsCTD/eCTD dossier formatsPharmacovigilanceMS OfficeDocumentationCommunication
Free
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Regulatory AffairsCTD/eCTD dossier formatsPharmacovigilance
About the Role
Annora Pharma seeks a Regulatory Affairs Officer with 3-4 years of pharmaceutical experience in the UAE. The role involves preparing regulatory dossiers, ensuring compliance with local regulations, and maintaining product licenses.
Key Skills for This Role
Regulatory AffairsCTD/eCTD dossier formatsPharmacovigilanceMS OfficeDocumentationCommunication
Responsibilities
- Prepare and submit regulatory dossiers for product registration, renewal, and variations in the UAE
- Ensure compliance with local regulations, guidelines, and applicable international standards
- Respond to regulatory queries as needed
- Maintain regulatory databases and ensure timely updates of product licenses
- Review artworks to ensure regulatory compliance
- Liaise with internal departments (Supply Chain, Marketing) and external partners
- Track submission timelines and follow up on approvals
- Perform pharmacovigilance and post marketing regulatory activities as required
- Stay updated with changes in regulatory requirements and communicate impacts internally
Requirements
- Bachelor's or master's degree in pharmacy (B Pharm/M Pharma)
- 3 4 years of experience in Regulatory Affairs within UAE
- Good knowledge of UAE regulatory authorities' submission processes
- Familiarity with CTD/eCTD dossier formats
- Strong documentation, communication, and organizational skills
- Proficiency in MS Office applications
- PV and Pharmacist license preferred
Full Job Posting
Job Summary
- We are seeking a detail oriented Regulatory Affairs Officer with 3–4 years of experience in the pharmaceutical industry.
- The candidate will be responsible for ensuring compliance with local regulatory requirements, supporting product registrations, and maintaining regulatory documentation in line with UAE health authority guidelines.
- B Pharm/M Pharma candidate with PV and Pharmacist license is preferred.
Key Responsibilities
- Prepare and submit regulatory dossiers for product registration, renewal, and variations in the UAE.
- Ensure compliance with local regulations, guidelines, and applicable international standards.
- Respond to regulatory queries as needed.
- Maintain regulatory databases and ensure timely updates of product licenses.
- Review artworks to ensure regulatory compliance.
- Liaise with internal departments (Supply Chain, Marketing) and external partners.
- Track submission timelines and follow up on approvals.
- Perform pharmacovigilance and post marketing regulatory activities as required.
- Stay updated with changes in regulatory requirements and communicate impacts internally.
Qualifications & Requirements
- Bachelor’s / master’s degree in pharmacy, (B Pharm/M Pharma; Candidate with PV and Pharmacist license preferred)
- 3–4 years of experience in Regulatory Affairs within UAE.
- Good knowledge of UAE regulatory authorities’ submission processes.
- Familiarity with CTD/eCTD dossier formats.
- Strong documentation, communication, and organizational skills.
- Proficiency in MS Office applications.
Key Competencies
- Regulatory compliance awareness
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