Regulatory Affairs Senior Specialist Regional CoE

About AstraZeneca

AstraZeneca is a global biopharmaceutical company focused on the discovery, development, and commercialisation of prescription medicines for serious diseases. The company is undergoing a transformation in the Kingdom of Saudi Arabia, aligning with Saudi Vision 2030 to advance healthcare, innovation, and sustainable growth. AstraZeneca invests in talent, digital solutions, and new operational approaches to enhance patient outcomes and strengthen its leadership in therapeutic areas.

The Role of Regulatory Affairs Senior Specialist

The Regulatory Affairs team is integral to ensuring medicines reach patients safely, timely, and in compliance with global regulatory standards. AstraZeneca is seeking a Regulatory Affairs Senior Specialist to join its Regional Regulatory Centre of Excellence (CoE). This specialized unit is responsible for the operational delivery of Life Cycle Management (LCM) regulatory activities for Marketing Companies (MCs) across multiple markets. This full-time role requires 2-5 years of experience in regulatory affairs, a quality-focused mindset, and the ability to work in agile, matrixed, and multicultural environments.

Key Responsibilities

• Manage the operational delivery of LCM activities for assigned countries or clusters.
• Collaborate with MC teams, iRAMs, iRADs, and international iCMC teams to apply approved regulatory strategies and market-specific requirements.
• Prepare and customise high-quality submission packages for filing with Health Authorities.
• Coordinate responses to Health Authority queries and ensure timely availability of approved source documents and technical responses.
• Maintain regulatory systems and implement post-approval changes, including PSURs/PBRERs and safety data cutoffs.
• Manage label customisation, artwork coordination, implementation workflows, and compliance verification.
• Support product license maintenance, operational Marketing Authorisation Holder (MAH)-related activities, and divestment or transfer activities.
• Coordinate translations of Health Authority communications, approvals, and dossier components.
• Maintain accurate and timely records in RIM, ERV, and other required regulatory systems.
• Apply relevant LCM regulatory intelligence and escalate changes impacting strategy, content, timelines, supply, or compliance.
• Provide transparent status reporting, risk escalation, and decision records to relevant teams.
• Contribute to the development of standard templates, playbooks, dashboards, and automation initiatives.

Candidate Profile

The ideal candidate will have 2-5 years of experience in regulatory affairs. This role requires a professional with a strong focus on quality and the ability to operate effectively within agile, matrixed, and multicultural environments. The specialist will work closely with internal and external stakeholders to ensure regulatory compliance and timely market access for medicines.

Working at AstraZeneca

AstraZeneca fosters an inclusive culture that values diversity and collaboration. The company supports continuous learning, growth, and development for its employees, empowering them to advance scientific boundaries.