Regulatory Manager

Responsibilities

• Manage regulatory activities including registration, renewals, variation changes, and site transfers for assigned countries.
• Prepare submission dossiers in accordance with specific country requirements and regulations.
• Interact with health authorities throughout the product lifecycle and respond to agency queries.
• Provide regulatory support for tender business and initiate necessary pricing documentation.
• Develop and create new labeling and patient information leaflets according to local regulations.
• Review promotional materials and submit them for MOH approval where required.
• Evaluate regulatory risks of corporate policies and provide strategic guidance for product development.
• Monitor emerging regulatory issues and analyze the implications of changing guidance.
• Perform Arabic to English and English to Arabic translations for regulatory documentation.

Requirements

• Bachelor's degree in a relevant field.
• 8-10 years of relevant experience within the pharmaceutical industry.
• Proven experience working within the UAE market.
• Proficiency in Arabic to English and English to Arabic translation.

About the Company

Abbott is a global healthcare leader that has been helping people reach their potential for more than 135 years. With a presence in over 160 countries, we create life-changing technologies across diagnostics, medical devices, nutrition, and branded generic medicines to help people live their best lives through better health.