Job description

The Regulatory Affairs Senior Manager in the Regional Regulatory CoE leads the operational delivery, governance and performance of LCM activities performed by the CoE on behalf of MC regulatory teams. Building on the accountabilities of an MC Regulatory Affairs Senior Manager, the role ensures that market work is transferred, prioritised and executed through a scalable regional model that reduces local operational workload without weakening local accountability or Health Authority relationships.

The role provides senior regulatory and CMC judgement, leads matrix delivery across countries and products, and establishes effective collaboration with MC regulatory leaders, International iRAMs, iRADs and iCMC. The Senior Manager ensures approved international strategies and source content are converted into complete, compliant country-ready packages and progressed through submission, Health Authority questions, approval or notification, implementation and closure.

Typical accountabilities

·   Lead the CoE assigned LCM portfolio and delivery scorecard in alignment with regional and MC business priorities, agreed service levels and compliance expectations.

·   Own demand intake, prioritisation, work allocation, capacity visibility and delivery governance for LCM activities transferred from participating MC teams.

·   Lead complex or high-impact dossier customisation and submission delivery, providing expert advice on country requirements, post-approval pathways, CMC change management and operational strategy.

·   Establish robust working relationships and processes with MC regulatory leaders, International iRAMs, iRADs, iCMC and cross-functional partners to reduce duplication and enable efficient hand-offs.

·   Ensure CoE teams prepare, compile, quality-check and deliver country-ready LCM packages, including Module 1 and administrative content, using approved international and CMC source materials.

·   Where applicable, lead the CoE labelling adaptation and implementation capability for assigned products, ensuring the team has the expertise, tools, templates and quality controls to deliver high-volume, multi-market labelling changes accurately and efficiently on behalf of MC teams.

·   Drive standardization and efficiency in workflows, including template development, country requirement playbooks, artwork coordination processes and automation opportunities, to reduce MC workload and improve right-first-time quality.

·   Lead or participate in regional and international delivery teams for complex submissions and provide expert regulatory advice on risks, options and mitigations.

·   Govern Health Authority question management for complex LCM activities, ensuring clear ownership, aligned responses, timely contributions and appropriate escalation to MC or international strategy owners.

·   Oversee approval or notification tracking, implementation of variations and commitments, and timely, accurate maintenance of RIM, ERV, and other regulatory systems.

·   Identify potential regulatory, CMC, supply, quality, resource and timeline risks to the regional LCM plan and lead or recommend mitigation actions.

·   Lead resolution of submission execution failures, portal rejections, administrative non-compliance or timeline breaches, identifying root causes, implementing corrective actions and communicating transparently with MC regulatory leaders and regional leadership.

·   Lead CoE performance management, including agreed objectives, throughput, timeliness, right-first-time quality, data quality, HAQ cycle time, implementation and closure performance.

·   Build CoE capability through coaching, knowledge sharing, workload management, development planning and deployment of subject-matter expertise across the team.

·   Drive best-practice sharing, standardisation, automation and continuous improvement for established-product LCM delivery.

·   Provide senior stakeholder updates and represent the CoE in regional, MC and international governance forums related to LCM for the assigned products..

·   Ensure compliance with GRP procedures, relevant AstraZeneca policies, GxP requirements, the Code of Ethics and cross-functional procedures.

End-to-end LCM delivery activities

·   Receive the approved LCM strategy, core dossier, source documents and CMC/non-CMC content from International iRAMs, iRADs and iCMC.

·   Confirm country requirements with MCs, prepare delivery and content plans, and identify content, data, translation or timeline gaps.

·   Customise dossiers for countries or clusters, including Module 1, national forms, cover letters, declarations, local administrative documents and ERV activities.

·   Compile and quality-check submission-ready packages, coordinate final MC validation and translation where needed, and ensure consistency with approved source content and the registered dossier.

·   Execute or support submission under the agreed country model, arrange administrative submission steps where applicable, and maintain submission evidence and regulatory records.

·   Track assessment, anticipate and coordinate Health Authority questions, obtain approved contributions from MCs, International iRAMs, iRADs and iCMC, and dispatch responses within timelines.

·   Track approval or notification, coordinate implementation of approved changes, update RIM, ERV, or successor systems as applicable, and confirm compliant closure.

Leadership, decision-making and scope

·   Operates with a high degree of autonomy and leads complex, ambiguous or high-impact LCM portfolios across markets.

·   Decides or recommends delivery models, prioritisation, work allocation, sequencing, quality controls, risk mitigation and governance within approved strategies.

·   Provides matrix leadership and may have direct people-management responsibilities where assigned, including objective setting, capability development, performance support and resource allocation.

·   Escalates international regulatory strategy to the responsible iRAD or iRAM, source CMC strategy and content to iCMC, and local legal, MAH, Health Authority relationship or market decisions to the responsible MC.

Essential skills and experience

·   University degree or equivalent professional qualification in pharmacy, science, chemistry, biology, engineering or a related discipline.

·   Extensive biopharmaceutical regulatory experience, including significant responsibility for established-product LCM, country submissions, labelling and regulatory CMC.

·   Proven experience leading complex regulatory delivery portfolios and multidisciplinary matrix teams across multiple products or markets.

·   Thorough knowledge of post-approval regulatory frameworks, country dossier requirements, Health Authority procedures, CMC change management and implementation controls.

·   Advanced portfolio, project, stakeholder, influencing, negotiation, risk-management and problem-solving skills.

·   Demonstrated ability to design operating models, manage demand and resources, govern performance, standardise processes and develop regulatory capability.

·   Excellent written and verbal English, cultural awareness, scientific judgement and senior-stakeholder communication capability.

Desirable skills and experience

·   Experience leading regional hubs, shared-service models, Centres of Excellence or transformation programmes.

·   Experience with Veeva RIM, ERV, regulatory intelligence, planning and analytics platforms.

·   Experience scaling automation, digital workflows, dashboards, quality systems or continuous-improvement solutions.

·   Experience implementing regulatory changes across small molecules, biologics or biotechnology-derived established products and with manufacturing, supply and quality interfaces.

Key relationships

·   Senior Area Regulatory Director and regional regulatory leadership.

·   Marketing Company Regulatory Affairs leaders and Regulatory Country Leads.

·   International iRAMs and iRADs.

·   iCMC product leads and submission contributors.

·   Regional CoE team and cross-functional partners in manufacturing, supply, quality, labelling, patient safety and regulatory operations.

·   Local distributors, external service providers and Health Authorities through the agreed MC operating model.

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.