Senior Regulatory Affairs Specialist, Regional CoE

AstraZeneca; Selangor; Presencial; MYR 120.000 - 180.000; Jornada completa

Descripción de la vacante

AstraZeneca is seeking a Senior Regulatory Affairs Specialist to manage end-to-end lifecycle activities for assigned markets. You will coordinate dossier preparation, submission processes and Health Authority interactions, ensuring country-specific content aligns with global strategies.

You will work with MC teams, iRAMs, iRADs and iCMC to deliver high-quality, country-ready packages and maintain regulatory records across RIM/ERV systems in a fast-paced, multicultural environment.

Formación

• University degree in pharmacy, science, chemistry, biology, engineering or a related discipline.
• Relevant biopharmaceutical regulatory experience, including hands-on experience in established-product maintenance and country dossier preparation.
• Knowledge of post-approval submissions, local administrative requirements, Health Authority query management, approval implementation and regulatory data maintenance.
• Ability to work across CMC and non-CMC content and to collaborate effectively with MCs, International iRAMs, iRADs and iCMC.
• Strong project coordination, attention to detail, problem-solving, written communication and stakeholder-management skills.
• Proficiency in English and ability to operate effectively in a multicultural, matrix and high-volume environment.

Responsabilidades

• Plan and deliver assigned product LCM activities in line with market plans and local requirements.
• Prepare, compile and customise submission dossiers, including Module 1 content and local forms.
• Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify gaps and secure sources.
• Execute or support timely submission according to the market operating model and maintain submission evidence.
• Track milestones and coordinate responses with MC and international partners.
• Coordinate labeling customization, artwork coordination and labeling maintenance where applicable.
• Support product licence maintenance and MAH-related operational activities for established products.
• Coordinate translations of Health Authority communications and dossiers with final MC validation.
• Maintain regulatory-system records (RIM, ERV) and apply regulatory intelligence to LCM changes.
• Provide status reporting, risk escalation and decision records to MC, CoE leadership and international partners.

Conocimientos

Project coordination

Attention to detail

Problem solving

Written communication

Stakeholder management

English proficiency

Educación

University degree

Herramientas

Veeva RIM

ERV

Regulatory platforms

Descripción del empleo

Job description

The Senior Regulatory Affairs Specialist in the Regional Regulatory CoE manages the operational delivery of LCM activities for assigned countries or clusters. Building on the typical activities performed within an MC regulatory team, the role carries out agreed dossier preparation, customization, submission coordination and execution where possible (e.g. portal upload, administrative filing), Health Authority query management, regulatory-system maintenance and implementation activities on behalf of MC teams.

The role works closely with MC regulatory colleagues and with International iRAMs, iRADs and iCMC. The CoE uses the approved international regulatory and CMC strategy and source content, applies market-specific requirements, and delivers high-quality, country-ready packages while maintaining clear validation and escalation

Typical accountabilities

• Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures.
• Prepare, compile and customise submission dossiers, including country-specific Module 1 content, national forms, declarations, cover letters, administrative documents and supporting records.
• Coordinate CMC and non-CMC content with International iRAMs, iRADs and iCMC; identify package gaps and secure timely, approved source documents and responses.
• Execute or support timely submission according to the agreed market operating model, including administrative submission steps and submission evidence where applicable.
• Follow dossiers throughout assessment, monitor milestones, anticipate possible Health Authority questions and coordinate complete, consistent and timely responses with MC and international partners.
• Obtain and track LCM approvals or notifications and coordinate implementation of variations, renewals, commitments and other post-approval changes, including coordination with PSURs/PBRERs and safety data cut offs in line with local requirements.
• Coordinate labeling customisation, artwork coordination and labeling implementation workflows, labeling compliance checks and responsible for labeling maintenance where applicable
• Support product licence maintenance, MAH-related operational activities, divestment or transfer activities for established products where assigned, and associated regulatory documentation.
• Coordinate translations of Health Authority communications, approvals and dossier components where required, with final validation by the responsible MC.
• Maintain accurate and timely RIM, ERV, and other required regulatory-system records in accordance with procedures, standards and KPIs.
• Apply regulatory intelligence relevant to LCM through approved channels; elevate changes that could affect strategy, content, timing, supply or compliance.
• Provide transparent status reporting, risk escalation and decision records to the MC, CoE leadership, International iRAMs, iRADs and iCMC.
• Contribute to standard templates, playbooks, dashboards, automation, lessons learned and continuous improvement to reduce duplication and MC workload.
• Collaborate cross-functionally in line with AstraZeneca values, maintain a self-learning mindset and support knowledge sharing across the CoE.

End-to-end LCM delivery activities

• Receive the approved core LCM strategy, core dossier, source documents and CMC/non-CMC content from International iRAMs, iRADs and iCMC.
• Confirm country requirements and potential bundling strategies 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

Decision-making and scope

• Works independently on defined and moderately complex established-product LCM packages within approved strategy, procedures and service standards.
• Makes tactical recommendations on dossier customisation, execution sequencing, administrative requirements, response coordination and operational risk mitigation.
• Escalates international regulatory strategy questions to the responsible iRAM or iRAD, source CMC questions to iCMC, and local market or Health Authority relationship decisions to the responsible MC/SARD.

Essential skills and experience

• University degree in pharmacy, science, chemistry, biology, engineering or a related discipline.
• Relevant biopharmaceutical regulatory experience, including hands‑on experience in established-product maintenance and country dossier preparation.
• Knowledge of post‑approval submissions, local administrative requirements, Health Authority query management, approval implementation and regulatory data maintenance.
• Ability to work across CMC and non-CMC content and to collaborate effectively with MCs, International iRAMs, iRADs and iCMC.
• Strong project coordination, attention to detail, problem‑solving, written communication and stakeholder‑management skills.
• Proficiency in English and ability to operate effectively in a multicultural, matrix and high‑volume environment.

Desirable skills and experience

• 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, reporting, automation or continuous‑improvement initiatives.

Key relationships

• Marketing Company regulatory teams and Regulatory Country Leads.
• International iRAMs and iRADs.
• iCMC product leads and contributors.
• Regional CoE leadership and colleagues.
• Manufacturing, supply, quality, labelling, patient safety, regulatory operations, local distributors and external service providers.

Date Posted

28-Sep-2026

Closing Date

27-Okt-2026

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.