Sr. Regulatory Affairs Specialist – Gulf Cluster

دبي - الإمارات

الراتب شهرياً: لم يكشف

تاريخ النشر: نُشرت منذ أكثر من 30 يومًا

عدد الوظائف الشاغرة: 1 عدد الوظائف الشاغرة

سجل للتقديم

ملخص الوظيفة

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:

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

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

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

Required Experience:

Senior IC

Job DescriptionKey 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 suppl...