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Regulatory Affairs Jobs in Selangor - October 2026 - Urgent Hiring
Showing 9 jobs results for
"regulatory affairs"
in Selangor
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Undisclosed
- 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. ...
Posted
8 days ago
Undisclosed
Petaling
- 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
- · Plan and deliver assigned product LCM activities in line with market plans, agreed priorities, internal objectives, local requirements and applicable global procedures. ...
Posted
a day ago
Undisclosed
- 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. ...
Posted
8 days ago
Undisclosed
Petaling
- 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.
- · Lead the CoE assigned LCM portfolio and delivery scorecard in alignment with regional and MC business priorities, agreed service levels and compliance expectations. ...
Posted
a day ago
Undisclosed
- 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. ...
Posted
8 days ago
Undisclosed
- 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. ...
Posted
8 days ago
Undisclosed
- Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead
- Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions.
- Support with the oversight and management of international policy and intelligence scorecard KPIs, and its metrics for performance internally and externally ...
Posted
a day ago
Undisclosed
- Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead
- Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions.
- Support preparation of regulatory policy documents, including position statements, reports, draft papers and presentation materials. ...
Posted
a day ago
Undisclosed
Petaling
- Lead or manage regulatory policy priority topics as coordinated by the Global Regulatory Policy Team /International Policy and Intelligence lead
- Provide key regulatory procedural/ environmental advice on assigned topics to key customers/stakeholders within international and Global, including the Regulatory TAs, Commercial, MC regulatory, R&D, Operations and CMO functions.
- Support preparation of regulatory policy documents, including position statements, reports, draft papers and presentation materials. ...
Posted
a day ago
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