Regulatory Affairs Senior Specialist, Regional CoE

Regulatory Affairs Senior Specialist – Regional Centre of Excellence

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

SITE DESCRIPTION 

AstraZeneca is experiencing a significant transformation in the Kingdom of Saudi Arabia, driven by a commitment to advancing healthcare, innovation, and sustainable growth. Building on our global legacy, AZ KSA is rapidly evolving its operations to better serve patients, collaborate with healthcare stakeholders, and contribute to the ambitious goals outlined in the Saudi Vision 2030. We are investing in talent, digital solutions, and new ways of working; all designed to enhance our impact on patient outcomes and reinforce our leadership in therapeutic areas. This dynamic environment calls for visionary, agile professionals who thrive in change and are motivated to help shape the future of healthcare in KSA. 

ROLE SUMMARY

At AstraZeneca, we are driven by a bold ambition: to continue pioneering science to improve the lives of millions of people. Our Regulatory Affairs team is an essential part of that mission, ensuring that our medicines reach patients in a timely, safe manner and in compliance with the highest global regulatory standards.

We are seeking a Senior Regulatory Affairs Specialist to join our Regional Regulatory Centre of Excellence (CoE), a specialized unit that serves as the operational delivery arm for Life Cycle Management (LCM) regulatory activities on behalf of Marketing Companies (MCs) across multiple markets. If you have solid regulatory affairs experience, a quality-focused mindset, and the ability to work effectively in agile, matrixed, and multicultural environments, this is your opportunity.

The Senior Regulatory Affairs Specialist within the Regional CoE 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, applying approved regulatory strategies and market-specific requirements to produce high-quality submission packages ready for filing with Health Authorities.

The scope of the role covers dossier preparation and customization, coordination of responses to Health Authority queries, maintenance of regulatory systems, and implementation of post-approval changes.

What you’ll do

• LCM Planning and Delivery: Plan and execute assigned LCM activities in line with market plans, agreed priorities, internal objectives, local requirements, and applicable global procedures.
• Dossier Preparation and Customization: Compile and customize submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents, and supporting records. 
• CMC and Non-CMC Content Coordination: Coordinate with international iRAMs, iRADs, and iCMC teams to identify content gaps and ensure timely availability of approved source documents and technical responses
• Submission Execution: Execute or support the timely submission of dossiers according to the market operating model, including administrative steps and submission evidence where applicable.
• Health Authority Query (HAQ) Management: Monitor review milestones, anticipate Health Authority questions, and coordinate complete, consistent, and timely responses with MC and international partners.
• Approval Tracking and Implementation: Obtain and track LCM approvals or notifications and coordinate implementation of variations, renewals, commitments, and other post-approval changes, including PSURs/PBRERs and safety data cutoffs.
• Labeling Coordination: Manage label customization, artwork coordination, implementation workflows, compliance verification, and maintenance of labeling where applicable.
• License Maintenance and MAH Activities: Support product license maintenance, operational MAH-related activities, and divestment or transfer activities for asigned products.
• Translation Management: Coordinate translations of Health Authority communications, approvals, and dossier components, with final validation provided by the responsible MC.
• Regulatory Systems Maintenance: Maintain accurate and timely records in RIM, ERV, and other required regulatory systems in accordance with established procedures, standards, and KPIs.
• Regulatory Intelligence: Apply relevant LCM regulatory intelligence through approved channels, escalating changes that may impact strategy, content, timelines, supply, or compliance.
• Reporting and Risk Management: Provide transparent status reporting, risk escalation, and decision records to MC teams, CoE leadership, iRAMs, iRADs, and iCMC teams.
• Continuous Improvement: Contribute to the development of standard templates, playbooks, dashboards, automation initiatives, and lessons learned to reduce duplication of effort and workload for MC teams.

Essential Capabilities

• Education: Bachelor's degree in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory Experience: Minimum 4 years of relevant experience in biopharmaceutical regulatory affairs, including hands-on experience supporting assigned products and preparing country-specific dossiers.
• Technical Knowledge: Strong knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation, and regulatory data maintenance.
• Cross-Functional Capability: Ability to work with both CMC and non-CMC content and collaborate effectively with MC teams, iRAMs, iRADs, and iCMC teams.
• Professional Competencies: Strong project coordination, attention to detail, problem-solving, written communication, and stakeholder management skills.
• Language and Working Environment: Proficiency in English and the ability to operate effectively in a multicultural, matrixed, and high-volume environment.

Desirable Capabilities

• Experience with Veeva RIM, ERV, regulatory intelligence platforms, or comparable planning and document management systems.
• Experience supporting multiple markets, clusters, local distributors, or external submission partners.
• Experience with digital workflow initiatives, reporting, automation, or continuous improvement programs.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

• Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
• Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

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Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.