Contract: 12 months (renewable)

Employment: Outsourced through ManpowerGroup Middle East

Position Summary:

The Regulatory Coordinator supports regulatory activities across the Gulf and Saudi regions, ensuring timely and compliant submissions to Health Authorities (HAs). This role involves coordination of labeling, lifecycle management, documentation, and administrative tasks, in alignment with company standards and local regulations.

Key Responsibilities:

Regulatory Submissions

• Prepare and support new and ongoing product submissions (eCTD and paper) to local HAs.
• Coordinate with global and local teams to ensure timely and accurate submission packages.

Labeling

• Prepare, track, and archive labeling files.
• Coordinate creation of Arabic inserts and 3D images for Saudi submissions.
• Support product label updates and liaise with translators and vendors.
• Collaborate with Medical Advisors for proofreading and finalizing Arabic inserts.
• Request artwork layouts from the global artwork team and ensure alignment between Arabic and English texts.
• Maintain label compliance with cpmpany SOPs and local regulations.
• Monitor submission and approval timelines for label updates.
• Participate in local labeling and supply/quality update meetings.
• Labeling Assessment in VERITY for all assets.
• Track & monitor labeling activities in VERITY.
• Support e-labeling (SDI & Nashratech).
• Manufacturing Site Registration/Renewal.

Lifecycle Management

• Manage lifecycle activities for registered drug products.
• Track license renewals and notify Country Regulatory Managers (CRMs) 6–9 months prior to expiry.

Regulatory Support

• Attend quarterly Gulf Compliance Committee meetings and monitor compliance topics.
• Liaise with local partners to support daily regulatory operations.

Documentation & Systems Management

• Ensure regulatory systems (VERITY, Regulatory SharePoint) reflect current approved labels.
• Archive regulatory files, submission documents, correspondence, and artworks electronically.
• Conduct monthly Verity checks and generate reports for compliance tracking.

Cross-functional Collaboration

• Engage with global regulatory colleagues and labeling leads on submissions.
• Maintain accurate entries in GRS tracking systems and archives.
• Collaborate with internal teams across functions.

Administrative Support

• Manage regulatory documentation (electronic and hard copy).
• Raise purchase orders for local teams and Middle East distributors.
• Organize and support team trainings, meetings, and GRS coordination.
• Attend monthly GRS meetings and follow up on action items.

Qualifications:

• Bachelor’s degree in a scientific or related discipline.
• 2–3 years of experience in regulatory affairs or a related pharmaceutical field.
• Knowledge of regulatory submission processes and requirements.
• Experience with eCTD and paper submissions.
• Strong organizational and project management skills.
• Excellent communication and interpersonal abilities.
• Proficiency in regulatory systems (e.g., VERITY) and Microsoft Office Suite.

Preferred Qualifications

• Experience working with Middle Eastern regulatory authorities.
• Familiarity with CMC amendments and drug product lifecycle management.
• Experience in labeling and artwork review processes.

Core Competencies

• High attention to detail and accuracy.
• Strong problem-solving capabilities.
• Ability to work independently and collaboratively.
• Adaptability in a fast-paced environment.