Sr. Regulatory Affairs Specialist – Gulf Cluster

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 ensure high quality labelling translation, review and artwork 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.
• Support 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.
• Maintain 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.

• Minimum of 4–5 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.

Dubai

Active Listening, Detail-Oriented, Listening Effectively, Pharmaceutical Regulatory Affairs, Problem Solving, Product Registrations, Project Management

Relocation:
Not specified. Visa sponsorship:
Not specified. Travel requirements:
Not specified. Hybrid work arrangement:
Yes.