ManpowerGroup Middle East provides workforce solutions and staffing services across the region. This role is outsourced through ManpowerGroup to support a client in the pharmaceutical sector.

Role Overview:
The Regulatory Affairs Coordinator will support regulatory activities across the Gulf and Saudi regions, ensuring timely and compliant submissions to Health Authorities. The role includes regulatory submissions, labeling, lifecycle management, documentation, and cross-functional coordination. This is a 12-month renewable contract, based in Dubai.

Key Responsibilities:

Regulatory Submissions:

• Prepare and support new and ongoing product submissions (eCTD and paper) to local Health Authorities.

• Coordinate with global and local teams for accurate submission packages.

Labeling:

• Track, prepare, and archive labeling files.

• Coordinate Arabic inserts and 3D images for Saudi submissions.

• Support product label updates and liaise with translators and vendors.

• Ensure label compliance with SOPs and local regulations.

Lifecycle Management:

• Track license renewals and notify Country Regulatory Managers 6–9 months prior to expiry.

• Manage lifecycle activities for registered drug products.

Regulatory Support:

• Attend Gulf Compliance Committee meetings and monitor compliance topics.

• Liaise with local partners to support daily regulatory operations.

Documentation & Systems Management:

• Maintain regulatory systems (VERITY, Regulatory SharePoint) with current approved labels.

• Archive regulatory files, submission documents, correspondence, and artworks electronically.

Cross-functional Collaboration:

• Collaborate with global regulatory colleagues, labeling leads, and internal teams across functions.

• Maintain accurate entries in tracking systems and archives.

Administrative Support:

• Manage regulatory documentation and raise purchase orders.

• Organize team trainings, meetings, and GRS coordination.

Key Requirements:

• Bachelor’s degree in a scientific or related discipline.

• 2–3 years of experience in regulatory affairs or pharmaceutical field.

• Knowledge of regulatory submission processes (eCTD/paper) and labeling.

• Strong organizational, project management, and communication skills.

• Proficiency in regulatory systems (e.g., VERITY) and MS Office.

Preferred Qualifications:

• Experience with Middle Eastern regulatory authorities.

• Familiarity with CMC amendments and drug lifecycle management.

• Experience in labeling and artwork review processes.

Core Competencies:

• High attention to detail and accuracy.

• Problem-solving capability.

• Ability to work independently and collaboratively in a fast-paced environment.