Regulatory Affairs Specialist

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

• 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.
  
  

Minimum Requirements

• 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.
  
  

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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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