Regulatory Affairs Specialist

Develop and maintain a product database of all Alcon portfolio and their status in Middle East

• Maintain an up-to-date local regulatory archive for Alcon products and regulations (corporate dossier, submitted documents, registration certificates, etc.)

• Act as point of contact to receive and compile regional Regulatory surveys for Middle East to be reviewed by the Regulatory Affairs Manager

• Secure fast registration, renewal and variation submission and approvals of Alcon products in Middle East

• Secure fast submission of internally approved promotional materials through local distributors

• Pre-align with the Regulatory Affairs Manager/Director on the needed action and priority for each product based on local market /RA needs & corporate strategy and Regional Specificities.

• Support the Regulatory Affairs Manager/ Director to set proper product launch plans by proactively communicating and sharing registration status, packaging material approvals and or any challenges due to change in regulations.

• Maintain good relationships with local authorities and associations, where applicable.

• Assists in the Arabic-to-English and English-to-Arabic translation of product information and checks for translation accuracy in the product packaging and product package inserts/label/ Instruction for Use

• Perform in accordance with Alcon’s Patient Safety and Quality Management Guidelines

WHAT YOU’LL BRING TO ALCON:

• Bachelor’s degree in biomedical Engineer or Science related degree

• Fluent English and Arabic (written and spoken)

• Minimum 3 years’ experience in a Regulatory Affairs position in Middle East in a multinational Medical Company

• Extensive knowledge of Regulatory Affairs environment (processes, organization, legislation, …) in 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 collaboration skills, the ability to work in a matrix organization and experience working in a partnership environment, and excellent in influencing others without direct hierarchic link.

• Strong mental agility, motivation and high commitment are required to deal with the variety of therapeutic & diagnostic indications, product segments and market access strategies.

• Strong interpersonal skills are mandatory for this position; communication, business and customer-oriented approach.