Regulatory Affairs Specialist
Novartis
Date: 3 weeks ago
City: Riyadh
Contract type: Full time
Summary
Be the bridge between innovation and patient safety—As a Regulatory Affairs Specialist in Saudi Arabia’s dynamic healthcare landscape, you’ll play a pivotal role in shaping the future of medicine. From ensuring compliance with SFDA regulations to accelerating access to life-saving therapies, your expertise drives both public health and industry growth. Join a mission where precision meets purpose, and every regulation you navigate brings better care to millions.
About The Role
Major Accountabilities
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Be the bridge between innovation and patient safety—As a Regulatory Affairs Specialist in Saudi Arabia’s dynamic healthcare landscape, you’ll play a pivotal role in shaping the future of medicine. From ensuring compliance with SFDA regulations to accelerating access to life-saving therapies, your expertise drives both public health and industry growth. Join a mission where precision meets purpose, and every regulation you navigate brings better care to millions.
About The Role
Major Accountabilities
- New Product Registrations – With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favorable outcome
- Maintenance of registered products – With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the DRA manager/Head).
- Coordinate with DRA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
- Maintain, with supervision, the internal DRA database accurate and updated: Dragon/DASA
- Relationships within and outside the company - Develop and maintain good working relationships with other Novartis departments both locally and with Head Office and with third-party vendors.
- With Supervision, Review PPMS and ensure AQWA Launch request are prepared and launched on time.
- With Supervision, ensure full support to Global regulatory compliance initiatives in Saudi.
- Pharmacy or related science degree.
- Minimum 1 year of RA Experience in reputable pharmaceutical company.
- Experience handling a portfolio/product and dealing with stakeholder such as SFDA and governmental agency.
- Must be Saudi national.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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