Senior Regulatory Affairs Specialist, Regional CoE

About the role

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to join its Regional Regulatory Centre of Excellence in Riyadh. The CoE delivers Life Cycle Management (LCM) regulatory activities for marketing companies across several markets, and the specialist manages the operational delivery of LCM activities for assigned countries or clusters. The role works closely with MC teams, iRAMs, iRADs and international iCMC teams to prepare high-quality submission packages for Health Authorities.

Key responsibilities

• Plan and execute LCM activities in line with market plans, priorities, local requirements and global procedures.
• Compile and customize submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters and supporting records.
• Coordinate with international CMC and non-CMC teams to close content gaps and secure approved source documents and technical responses.
• Execute or support timely submissions, including administrative steps and submission evidence.
• Monitor review milestones and coordinate complete, consistent responses to Health Authority queries.
• Track approvals and implement variations, renewals, commitments and post-approval changes, including PSURs/PBRERs and safety data cutoffs.
• Manage label customization, artwork coordination, compliance verification and labeling maintenance.
• Support product license maintenance, MAH activities and divestment or transfer activities.
• Coordinate translations of Health Authority communications and approvals, validated by the responsible marketing company.
• Maintain records in RIM, ERV and other regulatory systems, and apply regulatory intelligence, escalating changes that affect strategy, content, timelines, supply or compliance.
• Provide status reporting, risk escalation and decision records, and contribute to templates, playbooks, dashboards, automation and lessons learned.

Required profile

• Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering or a related discipline.
• Minimum 4 years of biopharmaceutical regulatory affairs experience, including hands-on support of assigned products and preparation of country-specific dossiers.
• Strong knowledge of post-approval submissions, local administrative requirements, Health Authority query management and regulatory data maintenance.
• Ability to work with CMC and non-CMC content and with MC, iRAM, iRAD and iCMC teams.
• Proficiency in English and ability to work in a multicultural, matrixed, high-volume environment.

Required skills

• Desirable: experience with Veeva RIM, ERV or comparable planning and document management systems.
• Desirable: experience supporting multiple markets, clusters, local distributors or external submission partners.
• Desirable: experience with digital workflow, reporting, automation or continuous improvement programs.