Regulatory Affairs Specialist At Alcon Egypt
Location: New Cairo
The Regulatory Affairs Specialist is responsible for coordinating various regulatory affairs activities including but not limited to; products submissions, renewals and updates by coordinating between plants and agents and continuously communicating with all parties involved (including governmental and official authorities) to ensure timely submission and approvals.
Put the registration plans from the beginning of registration till launching the products.
Follow up the post approval activities.
Ensure fast registration and reimbursement of Alcon products, updating existing files, through continuous coordination between RA teams in Alcon and agents, as well as health authorities.
Develop and maintain a product database of all Alcon products’ regulatory status in the region and
Define the priority of each project (product – market) based on corporate strategy and Regional Specificities.
Guarantee the best price to achieve the planed profit margin.
Ensure timely acquisition of finished products conformity sheets issued from NODCAR and accordingly the timely release of the finished product as per marketing plan.
Complying with global and local regulatory guidelines.
Guarantee approvals of all types of local and global variations.
Securing the routinely release of already registered and marketed products.
To insure compliance with the local M.O.H.
Supportive aid to DRA team or any other department in Alcon in solving any pending issues with legal department or higher management of central administration of pharmaceutical affairs.
Support/Lead Head of RA in country/region projects related to the department.
Establish and maintain good relationships with Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility and priority to Alcon products registration.
Control timelines (submissions – approvals- introductions) to cope with country plans & strategies as well.
Medical background, preferably pharmcist.
3 to 5 years of experience.
Medical devices regulatory experience is a must.
Fluent in English and Arabic.
Based in Cairo