ROLE PURPOSE:

• Execute regulatory affairs activities to meet departmental and business goals while ensuring compliance with health authority regulations in assigned markets.
• Ensure alignment with the company’s internal procedures for regulatory standards.
• Define, determine, and communicate regulatory requirements and due diligence to stakeholders and project teams.
• Collaborate with cross-functional teams to manage the entire process from concept/development to artwork release for regulatory artwork changes.

REGULATORY & LABELLING RESPONSIBILITIES:

Regulatory Documents Submission:

• Compile and submit regulatory documents (new registrations, variations, etc.) according to local requirements.
• Ensure timely follow-up on submissions and manage timely deficiency responses.
• Prioritize high-margin products aligned with business objectives.
  
  

Regulatory Tracking:

• Update regulatory trackers with accurate information and provide input for regulatory plans.
  
  

Documents Archiving:

• Archive submitted dossiers (soft copies) in shared folders and Veeva RIMs as applicable.
  
  

Regulatory Guidelines Support:

• Develop a detailed understanding of regulatory guidelines and technical requirements for assigned countries.
  
  

Regulatory Plans Execution:

• Collaborate with the regulatory manager to develop and implement regulatory plans for complex projects (e.g., product transfers, life cycle maintenance, etc).
  
  

Renewals Management:

• Manage product and site renewals for the assigned markets by adhering to submission deadlines in the renewal tracker.
  
  

Cross Functional Support:

• Provide solutions to a variety of problems of moderate scope of complexity. Interacts with internal and/or external stakeholders.  Identifies and responds appropriately to issues, providing adequate solutions.
• Work cross functionally on new products launches and products acquisition. Build better and stronger relationships with relevant internal and external stakeholders
  
  

Labelling & Artwork Management (Local/Global IPs):

• AW word files development, annotation and review of the artworks in compliance with local labelling guidelines ensuring quality control English version as well as the Arabic translation to have robust texts.
• Mock-ups creation to support various types of submissions (on Pulse system or with 3rd parties).
• Artwork release post MOH approval and ensures all relevant stakeholders are informed as needed (on Pulse system or with 3rd parties).
• Maintain AW tracker and archives for all the ongoing changes for the artworks.
  
  

Compliance:

• Ensure adherence to the company’s SOPs and work instructions.
  
  

RA Team Support: 

• Work on assigned projects to assist other team members where needed based on the business priorities
  
  

Regulatory Guidelines Monitoring:

• Monitor changes in the healthcare regulatory environment and communicate updates to relevant stakeholders for implementation.