Sr. Regulatory Affairs Specialist – Gulf Cluster

Job Description

Key responsibilities:

• Ensure timely preparation submission and appropriate follow-up & approval of new Marketing Authorization applications to the local authorities.
• Ensure maintenance of assigned authorized products through timely submission of variations renewal applications and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation review andartwork management including submission follow up approval communication systems update and implementation.
• Ensure all relevant systems updates Regulatory compliance quality new system implementation and digital processes
• Supports the agency interactions to ensure a seamless submission assessment and quick approval of the assigned Therapeutic Areas / portfolio according to the new regulations in cooperation with other internal stakeholders.
• Stay updated on international and local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant Stakeholders appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts on sub-regional regional and global level and cross functional stakeholders.
• Maintain professional relationship with External parties as Agents and health authorities contacts as well as other key players in the regulatory environment.

Requirements:

• Minimum of 45 years of regulatory experience in the GCC region is an asset preferably in multinational pharma companies.
• Strong communication (Bilingual: in English and Arabic) and active listening skills; able to tailor messages to diverse stakeholders.
• Proven experience in cross-functional collaborations; ability to work harmoniously within teams.
• Adaptability and ability to work in a multicultural environment
• Strategic thinking & problem-solving skills and Digital capabilities
• Time management multitasking and deadline adherence (timely KPIs compliance focus).
• AI knowledge & application as a plus.

Position location: Dubai

Required Skills:

Preferred Skills:

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