Regulatory Affairs Specialist

Job description

Job Description

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.

Desired profile

Education: Pharmacy degree , Health Economics or Medical Related Sciences
Languages: Fluent in English and Arabic
Experience: Minimum 3 years' experience in a RA position (ME region) in a pharmaceutical Company.
Preferably in both surgical / medical devices and pharmaceuticals.
Competency/Technical Skills:
 Extensive knowledge of RA environment (processes, organization, legislation, …) in the Middle East
 Highly organized with a keen sense of what it takes to get the job done; strong operating skills and a sense of urgency.
 Must have strong collaborations skills, the ability to work in a matrix organization and experience working in a partnership environment, excellent in influencing others without direct hierarchic link.
 Strong mental agility and motivation are required to deal with the variety of therapeutic indications, product segments and market access strategies. Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach.
 Ability to build and influence external contacts