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 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:

Current Employees apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

01/24/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
  

Requisition ID:R377539