Regulatory Affairs Senior Manager, Regional CoE

Regulatory Affairs Senior Manager, Regional Regulatory 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, and compliant manner while meeting the highest global regulatory standards.

AstraZeneca is seeking a Regulatory Affairs Senior Manager to join the Regional Regulatory Centre of Excellence (CoE) and lead the operational execution of Life Cycle Management (LCM) activities for assigned products across assigned markets.

The role requires a combination of senior regulatory expertise, technical and CMC judgment, matrix leadership, portfolio management, and the ability to drive scalable and efficient operating models. The position will contribute to reducing the operational burden on local teams while maintaining the Marketing Companies’ accountability for market decisions, health authority interactions, and local legal obligations.

What you’ll do

• LCM Portfolio Leadership: Lead the regional Life Cycle Management portfolio, ensuring alignment with business priorities, agreed service levels, and quality and compliance expectations.
• Demand and Resource Management: Manage intake, prioritization, work allocation, capacity visibility, and governance of activities transferred from Marketing Company teams.
• Operational Strategy and Regulatory Execution: Lead complex or high-impact activities related to dossier customization, regulatory submissions, national requirements, post-approval pathways, and CMC change management.
• Dossier Preparation: Ensure the preparation, compilation, and quality review of country-ready regulatory packages, including Module 1, national forms, cover letters, declarations, local administrative documentation, translations, and ERV activities where applicable.
• Submissions and Tracking: Execute or support regulatory submissions under the agreed operating model, maintain submission evidence, and ensure regulatory records remain complete and current.
• Health Authority Questions Management: Coordinate the receipt, assignment, consolidation, and timely submission of responses to health authority questions, ensuring appropriate involvement of Marketing Companies, iRAMs, iRADs, and iCMC.
• Implementation and Closure: Oversee approval follow-up activities, implementation of variations and commitments, regulatory system updates, and compliant closure of activities.
• Labeling Adaptation and Implementation: Where applicable, lead regional capabilities for labeling adaptation and implementation, ensuring appropriate use of tools, templates, and quality controls.
• Standardization and Continuous Improvement: Design and enhance processes, templates, national requirements guides, artwork coordination workflows, and automation opportunities to improve efficiency and right-first-time quality.
• Risk Management: Identify and manage regulatory, CMC, supply, quality, resource, and timeline risks, recommending and implementing appropriate mitigation measures.
• Issue Resolution: Lead the investigation and resolution of portal rejections, administrative non-compliance, execution failures, or schedule deviations, including root cause analysis and implementation of corrective actions.
• Governance and Performance Management: Manage performance indicators related to workload volume, timeliness, right-first-time quality, data quality, response times to health authority questions, implementation, and activity closure.
• Leadership and Capability Building: Provide matrix leadership, coaching, knowledge transfer, development planning, and deployment of specialized expertise within the team.
• Stakeholder Management: Build strong relationships with Regulatory leaders in Marketing Companies, iRAMs, iRADs, iCMC, and partners across Manufacturing, Supply, Quality, Labelling, Patient Safety, and Regulatory Operations.
• Compliance: Ensure activities are executed in accordance with Good Regulatory Practice (GRP), AstraZeneca policies, GxP requirements, the Code of Ethics, and applicable functional procedures.

Essential Capabilities

• Education: University degree or equivalent professional qualification in Pharmacy, Science, Chemistry, Biology, Engineering, or a related discipline.
• Regulatory Experience: Minimum 7 years of extensive experience in regulatory affairs for biopharmaceutical products, including significant responsibility for Life Cycle Management of assigned products, national submissions, labeling, and regulatory CMC activities.
• Multinational Experience: Experience working across multiple markets, products, and national regulatory requirements within a regional or international environment.
• Technical Knowledge: Strong understanding of post-approval regulatory frameworks, national dossier requirements, health authority procedures, CMC change management, and implementation controls.
• Portfolio Leadership: Demonstrated experience leading complex regulatory portfolios and cross-functional matrix teams.
• Stakeholder Management: Ability to collaborate, influence, negotiate, and align local, regional, and global teams, as well as technical and functional partners.
• Communication: Excellent written and verbal communication skills in English, with the ability to present technical information, risks, alternatives, and recommendations to senior stakeholders.
• Autonomy and Professional Judgment: Ability to make operational decisions, set priorities, and manage complex or ambiguous situations with a high degree of autonomy.
• Scientific and Regulatory Judgment: Ability to evaluate technical and regulatory information, identify gaps, and provide practical, evidence-based recommendations.
• Systems and Data Management: Experience using regulatory information systems, records management tools, submission tracking systems, and regulatory data maintenance processes.

Desirable Capabilities

• Experience leading Centres of Excellence, regional hubs, shared services models, or transformation programs.
• Experience with Veeva RIM, ERV, or other regulatory planning, analytics, and management platforms.
• Experience implementing automation, digital workflows, dashboards, or continuous improvement solutions.
• Experience working with small molecules, biologics, or biotechnology-derived products.
• Experience partnering with Manufacturing, Supply, Quality, Labelling, and other functions involved in post-approval change implementation.

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

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram  

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.