Qualified Person - Regulatory Affairs
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Key skills for this role
Role Overview
The employer is seeking a Qualified Person (QP) in Regulatory Affairs for a multinational pharmaceutical company based in Dubai, UAE.
The role acts as the Qualified Person or Responsible Pharmacist for pharmaceutical activities in the UAE.
Key Skills for This Role
Full Job Posting
Role Overview
The employer is seeking a Qualified Person (QP) in Regulatory Affairs for a multinational pharmaceutical company based in Dubai, UAE.
The role acts as the Qualified Person or Responsible Pharmacist for pharmaceutical activities in the UAE.
Responsibilities
- Act as the Qualified Person or Responsible Pharmacist for the company’s pharmaceutical activities in the UAE.
- Ensure compliance with applicable UAE regulatory, quality, and pharmaceutical requirements.
- Manage the full Regulatory Affairs lifecycle, including pharmaceutical product registration and licensing.
- Prepare, review, and submit regulatory documentation and dossiers to relevant local health authorities.
- Serve as the key point of contact with MOHAP/MOH and other relevant UAE health authorities.
Requirements
- Bachelor’s degree in Pharmacy or an equivalent qualification.
- Valid UAE Pharmacist License from MOHAP/MOH or another relevant UAE authority, as applicable.
- Previous experience as a Qualified Person, Responsible Pharmacist, or in a similar pharmaceutical regulatory role.
- Strong Regulatory Affairs experience in product registration, renewals, and variations.
- Previous experience working with pharmaceutical products in the UAE.
- Familiarity with local UAE regulatory requirements.
- Fluent Arabic and English communication skills are required.
- Oncology experience is highly preferred.
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