Regulatory Affairs Senior Specialist-GEM & Levant

Abbott; Dubai; On-site; AED 120,000 - 150,000; Full time

Job summary

A leading global healthcare company based in Dubai is seeking a Regulatory Affairs Senior Specialist. This role involves preparing and submitting regulatory dossiers while coordinating with health authorities. Candidates should have a Bachelor's degree in Pharmacy and 2-5 years of experience in regulatory affairs, along with strong communication skills in Arabic and English. This is a fixed-term contract for one year, providing an excellent opportunity to contribute to essential pharmaceutical services.

Qualifications

• 2-5 years of experience in Regulatory Affairs.
• Knowledge of registration requirements.

Responsibilities

• Prepare and submit dossiers according to country-specific requirements.
• Follow up on regulatory activities and plans for assigned countries.
• Provide regulatory support for tender business.
• Communicate with health authorities throughout the product lifecycle.

Skills

Regulatory Affairs knowledge

Communication skills

Analytical mindset

Bilingual (Arabic & English)

Education

Bachelor’s degree in Pharmacy

Job description

The Opportunity

• Regulatory Affairs Senior Specialist- GEM & Levant

This position works out of our UAE office in the Established Pharmaceutical division.

This is a fixed term contract role for 1 year.

About Established Pharmaceuticals—We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines covers multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management / central nervous system, and respiratory.

As Regulatory Affairs Senior Specialist, you'll be responsible for preparation and submission of dossiers according to country specific requirements and regulations.

What you'll do

Regulatory Affairs Coordination

Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety updates, pricing, labelling and site transfers.

Responsible for preparation and submission of dossiers according to country specific requirements and regulations.

Provide regulatory support for tender business.

Respond to agency questions and develop / coordinate appropriate responses.

Initiate the pricing documents based on each country's needs.

Develop and create new labeling printout according to country's regulations for our core products without any disruption of the existence of these products.

Communicate the updated patient Information Leaflet

Review promotional materials and submit to the agency in countries where MOH approvals are required.

Handle promotional material’s submission in MOH UAE.

Interaction with health authorities throughout the lifecycle of products.

Provide guidance to peers and other external partners

Coordinate regulatory organization processes with different partners in different countries.

Communicate efficiently with all business partners and employees.

Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.

Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations and information.

Re-challenge the HA and regulatory responsible on the variation’s tools and laws.

Required Qualifications

Bachelor’s degree of Pharmacy

Year of experience : 2-5 years

Experience in Regulatory Affairs. Registration requirement knowledge, Communication skills and analytical mindset.

Arabic & English language