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
Search Firm Representatives Please Read Carefully
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
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