REQ-10058966
7月 30, 2025
Saudi Arabia

摘要

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.


#LI-Onsite

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

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

Development
Innovative Medicines
Saudi Arabia
Riyadh
Research & Development
Full time
Regular
No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

REQ-10058966

Regulatory Affairs Specialist

Apply to Job
Research & Development Development Saudi Arabia