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Job Description
The role of Regulatory affairs supervisor is for the purpose of Ensuring the compliance of new products with regulatory requirements in the different middle east countries.
Main tasks:
- Prepare and submit registration, variation, and reimbursement files according to current Ministries/Health Authority requirements, approval of registrations, and sales Permissions.
- Prepare submission and follow-up of registration dossiers of new products and maintenance of all existing portfolios in the middle east.
- Prepare comprehensive documentations of complete product development processes.
- Coordination and review of the regulation/registration files and submission to the Competent Authorities.
- Follow up on new regulations, guidelines, curricular and related publications & inform management.
- Develop, review and maintain pharmacovigilance activities associated Standard Operating Procedures.
- Manage the written correspondence with the Ministry of Health before and after registration approval.
- Follow up global and local regulatory requirements.
- Maintain and update global and local regulatory systems.
- Monitor the healthcare and political environment and competitive landscape to capture events impacting market access of the medicines and advise Head of Market Access on actions to address threats and opportunities.
- Ensure that the company is compliant by different Ministries of Health rules and regulations with respect to warehousing and supply chain
- Implementation of registration management as defined by FMEME countries
- Follow up regularly for new and existing registrations of FME products in the middle east
- Coordinate with local FME Middle East sales and product managers for required products registrations, classification and clearance
Job Requirements
- Bachelor's degree Preferably in Pharmacy, Chemistry, Chemical Engineer, or related fields.
- At least 5 years of professional working experience in Regulatory Affairs, Reimbursement and preferably Pharmacovigilance in the Pharmaceutical and/or Medical Device Companies
- Knowledge of regulatory activities in both medical devices and medicinal products
- Knowledge of health economics, reimbursement and pricing policies and pharmacovigilance activities
- Fluent in English and Arabic both written and spoken.
Important personal qualities:
- Analytical thinking and problem-solving skills,
- Strong communication and presentation skills,
- Be dynamic, autonomous, and excellent team player
- Multitasking, managing, and meeting challenging deadlines with a positive attitude,
- Ability to prioritize tasks,
- Attention to detail
- Superior written and verbal communication skills
