Senior Regulatory Affairs Specialist, Regional CoE – LCM

AstraZeneca; Riyadh; On-site; SAR 300,000 - 460,000; Full time

Benefits offered by this job

Competitive healthcare

Job summary

AstraZeneca in Saudi Arabia is seeking a Senior Regulatory Affairs Specialist to join the Regional Centre of Excellence. You will drive lifecycle management, dossier preparation, and regulatory submissions across markets, coordinating with international teams and MC partners to ensure timely filings and post‑approval changes.

The role emphasizes strong project management, cross‑functional collaboration, and English proficiency in a multicultural setting.

Qualifications

• Bachelor’s degree in Pharmacy, Science, Chemistry, Biology, or Engineering.
• Minimum 4 years of regulatory affairs experience in biopharmaceuticals.
• Strong knowledge of post‑approval submissions and local regulatory requirements.
• Ability to work in a multicultural, matrixed environment.

Responsibilities

• LCM planning and delivery aligned with market plans and local requirements.
• Dossier preparation and customization including country content.
• Coordinate CMC and non‑CMC content with international teams.
• Submit dossiers and manage HAQ responses with partners.
• Track approvals and implement post‑approval changes.
• Manage labeling, MAH activities, and translations.
• Maintain regulatory systems and ensure KPI compliance.
• Apply regulatory intelligence and report risks to leadership.
• Contribute to templates, playbooks, and automation initiatives.

Skills

Regulatory affairs

Project coordination

Attention to detail

Problem-solving

Written communication

Stakeholder management

English proficiency

Education

Bachelor's degree in Pharmacy, Science, Chemistry, Biology, or Engineering

Tools

Veeva RIM

ERV

Regulatory intelligence platforms

Job description

AstraZeneca in Saudi Arabia is seeking a Senior Regulatory Affairs Specialist to join the Regional Centre of Excellence. You will drive lifecycle management, dossier preparation, and regulatory submissions across markets, coordinating with international teams and MC partners to ensure timely filings and post‑approval changes.

The role emphasizes strong project management, cross‑functional collaboration, and English proficiency in a multicultural setting.