Regulatory Affairs Senior Specialist, Regional CoE

AstraZeneca seeks a Senior Regulatory Affairs Specialist to join its Regional Centre of Excellence in Riyadh, managing life cycle management regulatory operations for assigned markets. The role involves dossier preparation, health authority coordination, and post-approval activities across multiple countries.

• Plan and execute life cycle management activities aligned with market plans and regulatory procedures
• Compile and customize submission dossiers with country-specific modules and administrative documents
• Coordinate with international teams to resolve content gaps and ensure timely availability of source documents
• Monitor health authority review milestones and coordinate responses to regulatory questions
• Maintain regulatory systems records and track approval implementation for variations and renewals

• Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or related field
• Minimum 4 years biopharmaceutical regulatory affairs experience
• Hands-on experience preparing country-specific regulatory dossiers
• Knowledge of post-approval submissions and health authority query management
• Ability to coordinate CMC and non-CMC regulatory content
• Strong project coordination, written communication, and stakeholder management skills