Pharmaceutical Associate Regulatory Affairs – Dubai

Pharmaceutical Associate Regulatory Affairs – Dubai vacancy at a leading Biotechnology Company in Dubai, UAE with the following:

Job Responsibilities

• Prepare, compile, and submit regulatory dossiers and product registration files to the UAE Ministry of Health and Gulf regulatory authorities (MOHAP, SFDA, DHA, etc.).
• Ensure all regulatory submissions are completed within timelines and comply with corporate standards and GCC pharmaceutical regulations.
• Review and approve promotional and non-promotional materials, packaging, and labeling to meet local regulatory and pharmacovigilance guidelines.
• Coordinate with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) for regulatory strategies, product lifecycle management, and post-approval updates.
• Monitor and communicate changes in GCC pharmaceutical legislation, drug safety regulations, biologics guidelines, and healthcare compliance laws.

• Maintain updated records of marketing authorizations, variations, renewals, clinical trial approvals, and regulatory documentation.
• Support the regulatory process for new drug applications (NDA), biologics license applications (BLA), and variations submissions in UAE and Gulf countries.
• Participate in internal audits to ensure GMP, GCP, and GVP compliance across regulatory operations.
• Collaborate with cross-functional teams as Pharmaceutical Associate Regulatory including Quality Assurance, Medical Affairs, Pharmacovigilance, Supply Chain, and Marketing.
• Provide regulatory intelligence and training to internal teams on UAE MOH requirements, GCC Drug Registration, and Gulf Cooperation Council Unified Procedures.

Job Qualifications – Pharmaceutical Associate Regulatory

• Bachelor’s degree in Pharmaceutical Science, Pharmacy, related field.
• Strong understanding of drug development process, regulatory submissions, GMP, and ISO standards.
• Experience working with Standard Operating Procedures (SOPs), documentation control, and regulatory compliance systems.
• Knowledge of UAE pharmaceutical regulations, Gulf Drug Registration guidelines, MOHAP processes, and GCC health authority requirements.
• Ability to interpret and communicate scientific, clinical, and regulatory information effectively.
• Excellent teamwork skills and ability to work in cross-functional regulatory environments.

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