Regulatory Affairs Coordinator

Anzaa Consultants; Dubai; On-site; AED 120,000 - 170,000; Full time

Job summary

A leading pharmaceutical multinational is seeking a Regulatory Affairs Coordinator in Dubai. This role involves compiling and coordinating regulatory dossiers, ensuring compliance with local and international regulations, and collaborating with cross-functional teams. The ideal candidate will have a degree in Pharmacy and 2–5 years of regulatory affairs experience, especially within the pharmaceutical industry. Benefits include a dynamic work environment and opportunities for professional development.

Qualifications

• 2–5 years of experience in Regulatory Affairs, ideally in manufacturing.
• Experience with UAE Ministry of Health, GCC-DR, and other Gulf regulatory bodies preferred.
• Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation.

Responsibilities

• Compile and review regulatory dossiers for product registrations.
• Work with regional regulatory teams and site-based functions.
• Maintain an organized archive of all regulatory submissions.
• Monitor submission timelines and ensure timely completion.

Skills

regulatory affairs

collaboration

coordination

GMP audits

Microsoft Office

document management

communication

CTD/eCTD dossier formats

compliance

Education

Bachelor’s or Master’s degree in Pharmacy

Job description

Our client is a leading pharmaceutical multinational with a manufacturing unit based in Dubai.

ROLE CONTEXT & PURPOSE

We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at the UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submissionto global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.

Key Responsibilities

Regulatory Documentation and Submission

• Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.
• Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.
• Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.
  
  

Cross-Functional and Regional Coordination

• Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).
  
  

Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.

Regulatory Records and Archiving

• Maintain an organized and up-to-date archive of all regulatory submissions made from the site.
• Implement proper version control, submission tracking, and document retrieval protocols.
  
  

Compliance and Process Management

• Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.
• Ensure alignment with both international regulatory expectations and local UAE/GCC requirements.
  
  

Reporting and Communication

• Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.
• Support documentation requests for internal audits, inspections, and compliance reviews.
  
  

CANDIDATE SPECIFICATION

• Bachelor’s or master’s degree in pharmacy (preferred)
• 2–5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.
• Preferred: Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.
• Practical knowledge of CTD/eCTD dossier formats and GMP audit preparation.
  
  

Key Skills and Competencies

• Strong communication, collaboration, and coordination skills across technical and regulatory functions.
• High level of accuracy, attention to detail, and document management capabilities.
• Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.
• Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.
• Proactive approach to problem-solving and handling regulatory queries.
  
  

Skills: regulatory affairs,collaboration,coordination,gmp audits,pharma,microsoft office,gmp,document management,communication,ctd/ectd dossier formats,manufacturing,compliance,pharmaceutical