Pharmaceutical Regulatory Affairs – Senior Executive

A leading pharmaceutical manufacturing company in Abu Dhabi, UAE is looking for an experienced Pharmaceutical Regulatory Affairs – Senior Executive -Senior Executive – Regulatory Affairs to join its growing regulatory and compliance team. This role is suitable for candidates with strong expertise in pharmaceutical regulatory affairs, dossier preparation, product registrations, and international regulatory compliance within GMP manufacturing environments.

Location: UAE
Industry: Pharmaceutical Manufacturing

Job Responsibilities

• Prepare, compile, review, and submit CTD/eCTD dossiers for pharmaceutical product registrations and approvals
• Handle product registration activities, renewals, variations, amendments, and lifecycle management for pharmaceutical products
• Ensure compliance with GCC, EU, WHO, ICH, and PIC/S regulatory requirements and pharmaceutical guidelines
• Coordinate with Quality Assurance, Quality Control, Production, R&D, Warehouse, and Supply Chain departments for regulatory documentation and submissions
• Maintain regulatory records, licenses, certificates, dossiers, and submission databases in accordance with company and authority requirements.

• Review product labels, packaging materials, artworks, inserts, and product claims to ensure regulatory compliance
• Support regulatory strategy and submission planning for new product launches and existing products
• Monitor updates and changes in pharmaceutical regulations and ensure implementation within the organization
• Communicate with health authorities and regulatory agencies regarding submissions, approvals, deficiencies, and compliance matters
• Support sterile and non-sterile pharmaceutical product registration and compliance activities
• Participate in GMP audits, inspections, and regulatory assessments
• Ensure timely completion of regulatory submissions according to defined timelines
• Maintain proper documentation practices in line with GMP and data integrity requirements
• Provide regulatory guidance and support to cross-functional teams during product development and commercialization
• Support oncology product registration and regulatory activities where applicable

Qualifications

• Minimum 7 years of experience in Regulatory Affairs within pharmaceutical manufacturing companies
• Strong experience in CTD/eCTD dossier preparation, compilation, and submission processes
• In-depth knowledge of GCC, EU, WHO, ICH, and PIC/S regulatory requirements
• Experience handling sterile and non-sterile pharmaceutical products
• Strong understanding of pharmaceutical product registrations, renewals, variations, and lifecycle management.

• Experience in oncology pharmaceutical products will be considered an advantage
• Good knowledge of GMP, pharmaceutical compliance systems, and regulatory documentation practices
• Strong communication, coordination, analytical, and organizational skills
• Ability to work effectively with cross-functional teams in a regulated pharmaceutical manufacturing environment
• Bachelor’s or Master’s Degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field preferred

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