Regulatory Affairs Senior Specialist – Regional Centre of Excellence

About the role

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to join its Regional Centre of Excellence in Saudi Arabia. The role supports Life Cycle Management (LCM) activities across multiple markets, ensuring high‑quality submission packages for health authorities.

Key responsibilities

• Plan and execute LCM activities in line with market plans, local requirements and global procedures.
• Prepare and customize country‑specific submission dossiers, including Module 1 content, forms, declarations and supporting documents.
• Coordinate with international iRAM, iRAD and iCMC teams to fill content gaps and provide timely technical responses.
• Manage health‑authority queries, track approvals, and implement post‑approval changes such as variations, renewals and safety reports.
• Maintain regulatory systems (RIM, ERV) and ensure accurate record‑keeping and reporting.

Required profile

• Bachelor’s degree in Pharmacy, Science, Chemistry, Biology, Engineering or related field.
• Minimum 4 years of biopharmaceutical regulatory affairs experience, including dossier preparation and post‑approval submissions.
• Strong project coordination, attention to detail and stakeholder‑management skills.
• Fluent in English and able to work in a multicultural, matrixed environment.

Required skills

• Experience with Veeva RIM, ERV or comparable regulatory planning and document‑management systems.
• Knowledge of post‑approval submission processes, health‑authority query handling and regulatory data maintenance.