Purpose:

To successfully manage Regulatory Affairs (RA) operations, compliance, and documentation activities to support GxP activities, and to ensure the timely completion of regulatory projects and submission of documentation, both internal and external, supporting the seamless execution of company business plans.

Major Accountabilities:

• Responsible for handling all the regulatory procedures for the MENA region including new product applications, renewals and lifecycle maintenance activities.
• Active involvement to ensure timely submissions and approvals as per the planned strategy to meet the launch timelines.
• Prepare and revise the responses to letters issued by the competent authorities during the evaluation of a new product, within a specific timeframe.
• Direct the requirements for specific labels and packaging in collaboration with logistics and supply chain team to ensure compliance with correct packaging according to registered products. Writing clear, accessible product labels and patient information leaflets.
• Establish and maintain professional relationship with business partners and competent authorities. Liaises with the competent authorities and local distributors in regard to all regulatory affairs related issues.
• Cross functional support including Logistics and supply chain, distribution Management and Sales and Marketing departments depending on the needs of the business. Support all registration and tender requests by coordinating the administrative part through applicable channels.
• Maintain a full up to date database for tracking the regulatory activities in the MENA region. Maintain accurate records of the final registration certificates and notify Global RA and local distributors six months before expiry to initiate the renewal process. Monitoring and setting timelines for license variations and renewal approvals.
• Specifying storage, labelling and packaging requirements. Review Temp tails for all shipments. Audit all local distributors in MENA region regularly and maintain Auditing Reports.
• Investigate customer complaints and non-conformance issues; develop, recommend, and monitor corrective and preventative actions.
• Create and update company SOPs. Maintain training records on all processes and regulations to comply with company\'s operating procedures.

Job Requirements:

• Bachelor degree in Pharmacy or equivalent, post graduate studies / MBA is a plus.
• Extensive experience in file compiling and submission for Medical Devices, Generic Products and New chemical entity products all over the MENA region, and specifically GCC with strong foothold in Saudi Arabia.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers and health authorities.
• Excellent computer proficiency (MS Office - Word, Excel, PowerPoint, and Outlook).
• Ability to work independently and to carry out assignments to completion within parameters of instructions given, prescribed routines, and standard accepted practices.
• Scientific and results-driven personality.

Antal International