Senior Regulatory Affairs specialist
Johnson & Johnson Middle East
Total years of experience :23 years, 9 Months
• Compile, prepare and submit regulatory documents (New license, Variation and Renewal Applications) on time to support new or existing product registrations.
• Prepare, follow up, and maintain Marketing Authorization Applications (MAA) according to current legislations.
• Develop ME Artworks to comply with the local regulations.
• Ensure the operational alignment of RA activities with other functional departments.
• Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical & consumer products with company standards & local applicable laws & regulations.
• Keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products.
• Specify the company objectives, developing policies and plans to achieve those objectives, and allocating resources so as to implement the company plans & goals.
• Strategy implementation.& Strategy formulation by making a situation analysis: both internal and external.
• Create, deliver, and communicate the company value to its target markets by territory management (Identifying a target market), strategically meets customer needs
• Self-development in the area of sales & marketing.
• Implementing the company goals in the market.
• Organizing the relation between the field force team & the higher management.
• Increase awareness on promotional brands.
• Cover all over UAE market From Abu Dhabi & Al Ain areas reaching to all over Dubai & Northern Emirates.
• Establish long-term relationship with major customers with the objective of developing & implementing the marketing strategies to achieve our target.
