Regulatory Affairs Specialist

2 weeks ago


مصر, Egypt Alcon Full time

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
- Ongoing registration.
- 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



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