Senior Regulatory Affairs Specialist Gulf Cluster

Merck Sharp & Dohme Corp; United Arab Emirates; Hybrid; AED 180,000 - 240,000; Full time

Job summary

A multinational pharmaceutical company seeks a Regulatory Affairs Specialist in Dubai. The role demands 4-5 years of experience in regulatory affairs within the GCC region, with proficiency in both English and Arabic. Responsibilities include preparing Marketing Authorization applications, maintaining authorized products, and supporting agency interactions for regulatory compliance. The position offers a hybrid work arrangement, targeting candidates with strategic thinking and problem-solving skills, and is ideal for someone with a strong track record in cross-functional collaborations.

Qualifications

• Minimum of 4–5 years of regulatory experience in the GCC region.
• Strong communication skills in English and Arabic.
• Proven experience in cross-functional collaborations.

Responsibilities

• Ensure timely preparation and follow-up of Marketing Authorization applications.
• Maintain authorized products through timely submission of variations.
• Support agency interactions for seamless submission and quick approval.

Skills

Active Listening

Detail-Oriented

Listening Effectively

Pharmaceutical Regulatory Affairs

Problem Solving

Product Registrations

Project Management

Job description

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 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
• 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 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.

Position location: Dubai

Required Skills:

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

Preferred Skills:

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Current Contingent Workers apply HERE

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

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Travel Requirements:

Flexible Work Arrangements: Hybrid

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Job Posting End Date: 01/24/2026

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