Regulatory Affairs Specialist

Riyadh - Saudi Arabia

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

Be the bridge between innovation and patient safetyAs a Regulatory Affairs Specialist in Saudi Arabias dynamic healthcare landscape youll 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.

Job Description

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

Skills Desired

Analytical Skill Clinical Trials Collaboration Detail-Oriented Lifesciences Project Planning Regulatory Compliance

Required Experience:

Unclear Seniority

Job Description SummaryBe the bridge between innovation and patient safetyAs a Regulatory Affairs Specialist in Saudi Arabias dynamic healthcare landscape youll play a pivotal role in shaping the future of medicine. From ensuring compliance with SFDA regulations to accelerating access to life-saving...