Medscience

Responsibilities

• Ensure the execution of the registration plan communicated by the regulatory affairs of each represented supplier in coordination with ministries and suppliers.
• Communicates with suppliers on the needed regulatory requirements for each formality such as registration, variation, pricing/re-pricing and drug importation as per country regulations.
• Prepares in close coordination with the suppliers the regulatory documents (technical dossier, price certificate, declaration letters…) and ensure their compliance with local regulations, to be sent to each local regulatory affairs contact for submission.
• Prepares with suppliers any requested form or clarification letter emerging from local health authorities in the region to be shared with other suppliers if necessary
• Gets the appropriate invoices from the suppliers based on local regulations of each country and review the correctness of Pro-forma invoices/drafts accordingly.
• Set up routinely meetings with local regulatory affairs to keep track of the submission plans.
• Follow up closely on submissions feedbacks in each country and report updates directly to the concerned supplier.
• Set a plan with the local regulatory affairs of each country based on the plan communicated with each supplier.
• Report to suppliers’ regular updates on regulatory laws and decisions in each country and follow-up on their translation if necessary.
• Communicate to suppliers and management in a timely manner concerning the products that are due for re-pricing.
• Coordinate compassionate use, named patient and urgent hospital requests for non-registered products to the Ministry of Health for approval
• Report to suppliers and management regular updates on MoH laws and decisions to act if necessary.
• Own the communication with the local regulatory affairs in each represented country in order to remain current on regulatory laws and act as an interface between the suppliers and the regulatory affairs representatives in each country.
• Carry out other duties that may include special missions assigned by direct supervisor, support to other units, providing on the job training, etc.
• Supports evaluation of new business opportunities

Experience & Qualifications

• Min. 5 years’ experience in similar position
• BS in Pharmacy, Regulatory Knowledge
• Broad experience across the MENA region with exposure to at least two of the three subregions (GCC, Levant, North Africa)

The role could be based out of either Beirut or Dubai.

Incorporated in the United Arab Emirates at the Dubai Science Park, Medscience is part of Fattal Group, one of the region’s leading distributors of premium brands. Medscience was formed to create an avenue for pharmaceutical manufacturers to establish & maintain product presence in smaller emerging markets and serve patients across the Middle East and Africa in an efficient and compliant manner. As a regional specialty pharmaceutical distributor, Medscience provides partners a simplified single contact alternative. We handle everything from market opportunity assessment, country prioritization and regulatory support to pre-launch and post launch commercialization. We are selective of the companies we represent to ensure close partnerships that are sustainable and lasting. We work with fast moving, fair minded, and professional organizations, sitting on leading edge of science and with a mission to deliver medicines that are truly going to change patients’ lives. The Medscience team takes pride in being an extension of each of our partners’ teams and businesses, with the interest of the patient and healthcare providers at heart.