Senior Regulatory Affairs Specialist, Regional CoE

AstraZeneca; Saudi Arabia; On-site; SAR 180,000 - 300,000; Full time

Job summary

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to join the Regional Centre of Excellence in KSA, driving lifecycle management for multiple markets. You will collaborate with MCs, iRAMs, iRADs, and iCMC teams to ensure compliant, timely submissions and post-approval changes.

The role emphasizes strong regulatory expertise, stakeholder coordination, and the ability to work in a multicultural, matrixed environment. English proficiency is required for global coordination.

Qualifications

• Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or related discipline.
• Minimum 4 years of regulatory affairs experience in biopharma, with country-specific dossier work.
• Strong coordination, communication, and stakeholder management skills.

Responsibilities

• Plan and deliver Lifecycle Management (LCM) activities for assigned markets.
• Prepare and customize submission dossiers with country-specific content.
• Coordinate with iRAMs, iRADs, and iCMC teams to address content gaps and responses.
• Manage HAQ timelines and ensure timely, complete responses.
• Track approvals and coordinate post-approval changes and labeling updates.

Skills

Regulatory affairs

Project management

English proficiency

Education

Bachelor's degree (Pharmacy/Science)

Tools

Veeva RIM

Job description

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to join the Regional Centre of Excellence in KSA, driving lifecycle management for multiple markets. You will collaborate with MCs, iRAMs, iRADs, and iCMC teams to ensure compliant, timely submissions and post-approval changes.

The role emphasizes strong regulatory expertise, stakeholder coordination, and the ability to work in a multicultural, matrixed environment. English proficiency is required for global coordination.