Regulatory Affairs Specialist

2 weeks ago

Riyadh, Saudi Arabia Alcon Full time

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
- As a Regulatory Affairs Specialist, you will facilitate the internal and external regulatory activities of Alcon portfolio with objective of smoothly registering / re-registering and maintaining Alcon products in compliance with the local legislations and business needs. Additionally, you will support business in Saudi Arabia through providing accurate regulatory information in a timely fashion to the different functions, whilst adhering to best practice principles and Alcon standard operational procedures, acting as a link between the organization, the distributors and the regulatory authorities wherever possible to ensure registration and supply in compliance with appropriate local legislation. In this role, a typical day will include:
Develop and maintain a product database of all Alcon portfolio and their status in Saudi Arabia- 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 Saudi Arabia to be reviewed by the Regulatory Affairs Manager
- Secure fast registration, renewal and variation submission and approvals of Alcon products in Saudi Arabia
- 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)-
- Saudi nationality-
- Minimum 3 years’ experience in a Regulatory Affairs position in Saudi Arabia in a multinational Medical Company-
- Extensive knowledge of Regulatory Affairs environment (processes, organization, legislation,) in Saudi Arabia-
- 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.-
- Ability to build and influence external contact.HOW YOU CAN THRIVE AT ALCON:
Competitive salary-
- Comprehensive benefits package-
- Training and continuous development; Be part of a high performing leader in ophthalmology company with a lot of opportunities to further develop your professional career.-
- International exposure-
- Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him/her to achieve goals and performance.Alcon Careers

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