Job Purpose:RA 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. The Specialist will also ensure ethical conduct and compliance with applicable national and international laws, codes and regulations.
Regulatory Affairs Specialist Responsibilities:
1. 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.
2. 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.
3. Establish and maintain good relationships with Ministry of Health, Regulatory authorities and Pharma associations, ensuring optimum visibility and priority to Alcon products registration.
4. Control timelines (submissions – approvals- introductions) to cope with regional plans & strategies as well as production plans and capacity through proactive communications with all relevant parties including RA, Packaging and SCM.
Job Role: Other
Company Industry: Pharmaceutical
Career Level: Mid Career