Regulatory Manager

Regulatory Manager working out of our UAE location in the Established Pharmaceutical Division. The role involves regulatory activities for assigned countries covering registration renewal, variation changes, safety issues, pricing, labelling, and site transfers.

• Follow up on regulatory activities and plans for assigned countries.
• Prepare submission dossiers according to country specific requirements and regulations.
• Coordinate and align all country's specific regulatory and registration requirements.
• Provide regulatory support for tender business.
• Respond to agency questions and coordinate appropriate responses.
• Initiate pricing documents based on each country's needs.
• Develop and create new labelling printouts according to country's regulations for core products.
• Communicate updated patient information leaflets.
• Review promotional materials and submit to t...