Regulatory Affairs Jobs in Selangor - October 2026 - Urgent Hiring

Showing 44 jobs results for "regulatory affairs" in Selangor
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MYR2,600 - MYR3,500 Per Month
Near Train Station
  • Ensure compliance with halal standards set by JAKIM
  • Manage halal certification, documentation, and renewal processes
  • Verify halal status of all ingredients and suppliers ...
Halal Certification Management Research and Development (R&D)
+5
Posted
a day ago
MYR6,500 - MYR8,500 Per Month
Near Train Station
  • Plan and prepare business presentations and carry-out follow-up meetings to government officials, related government agencies, current and potential customers.
  • Support development and project management on new and existing businesses.
  • Establish and maintain good relationships and reputation with all related government officials (Ministries, agencies, associations and embassies). ...
Automotive Industry knowledge in Customs
+3
Posted
14 days ago
MYR2,500 - MYR3,500 Per Month
  • Manage the daily administrative and operational activities of MCVTA.
  • Ensure smooth office administration and maintain proper filing, membership records, operational databases, statutory records, and compliance documentation.
  • Prepare meeting agendas, presentation materials, official correspondence, reports, resolutions, and minutes of meetings. ...
Administrative Support Scheduling
+8

Be an early applicant!

Posted
8 days ago
Undisclosed
Near Train Station
  • Build and enhance CARSOME’s relationship with relevant Government and Business stakeholders
  • Help to identify, arrange, and coordinate visits/ tours/ meetings/ engagements between Carsome and key Government
  • Business stakeholders such as CEOs, C-levels, Senior Executives, Ministers, senior civil servants, heads of agencies, regulatory bodies, and etc. ...
Posted
2 months ago
MYR2,600 - MYR3,500 Per Month
Near Train Station
  • Ensure compliance with halal standards set by JAKIM
  • Manage halal certification, documentation, and renewal processes
  • Verify halal status of all ingredients and suppliers ...
Halal Certification Management Research and Development (R&D)
+5
Posted
a day ago
MYR2,600 - MYR3,500 Per Month
Near Train Station
  • Ensure compliance with halal standards set by JAKIM
  • Manage halal certification, documentation, and renewal processes
  • Verify halal status of all ingredients and suppliers ...
Halal Certification Management Research and Development (R&D)
+5
Posted
a day ago
MYR2,600 - MYR3,500 Per Month
Near Train Station
  • Ensure compliance with halal standards set by JAKIM
  • Manage halal certification, documentation, and renewal processes
  • Verify halal status of all ingredients and suppliers ...
Halal Certification Management Research and Development (R&D)
+5
Posted
a day ago
  • Label & Artwork Review: Review and approve product labels, nutrition panels, ingredient lists, and packaging artwork to ensure strict compliance with local and export regulations.
  • Formulation & Additive Compliance: Assess product formulations, ingredients, and food additives against statutory master lists and regional food safety standards.
  • Regulatory Documentation: Compile, maintain, and manage regulatory databases, product registration dossiers, and export documentation. ...
Posted
a day ago

Malaysia

  • Ensure compliance with the various local and overseas product regulatory requirement.
  • Responsible in HALAL application and all related matters.
  • Prepare and monitor submission of license variation and renewals to strict deadlines. ...
Posted
5 days ago
  • Assist the Head of Regulatory in ensuring that safety reporting complies with Malaysia and International regulatory guidelines and Safety Data Exchange Agreements (SDEA) with Zuellig Pharma clients.
  • Be the contact person and liaison for Zuellig Pharma for Pharmacovigilance and Safety matters with NPRA, other relevant regulatory agencies and its clients. Guides Zuellig Pharma clients to prepare and ensure pharmacovigilance requirements are maintained, and service levels are met.
  • Provide guidance to the Regulatory Affairs Team and in terms of changes to regulatory and government policies related to Pharmacovigilance. Perform additional responsibilities under request of Head of Regulatory or Distribution Department as needed. ...
Posted
8 days ago

Bandar Bukit Raja

  • Oversee the end-to-end product registration process for local and international markets, ensuring timely submissions and compliance with applicable regulatory requirements.
  • Plan, coordinate, and execute Regulatory Affairs (RA) activities across designated markets, aligning regulatory strategies with business objectives and applicable standards.
  • Manage the complete regulatory lifecycle of products, including new registrations, approvals, variations, renewals, post-approval maintenance, and portfolio updates with relevant regulatory authorities. ...
Posted
13 days ago

Bandar Bukit Raja

  • Oversee and manage the entire process of product registration, ensuring compliance with regulatory requirements and timely submissions local and overseas.
  • Plan, coordinate, and execute Regulatory Affairs (RA) activities within the designated region, ensuring alignment with company objectives and regulatory standards.
  • Manage the full regulatory lifecycle of products, including initial submissions, approvals, variations, renewals, and ongoing maintenance with the national regulatory authorities. ...
Posted
14 days ago
  • Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
  • Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
  • Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements. ...
Posted
a day ago
  • KEY FUNCTIONS
  • Develop regulatory strategies, handle and oversea regulatory submissions, such as product registrations, renewals, variations and post-market surveillance reports.
  • Stay updated on changes in regulatory requirements and ensure organisation’s compliance with regulatory guidelines. ...
Posted
2 days ago
  • Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
  • Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
  • Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements. ...
Posted
14 days ago
  • Manage end-to-end regulatory submissions — including Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), amendments, safety reports, Development Safety Update Reports (DSURs), and annual reports — in full compliance with applicable regulations.
  • Translate regulatory requirements into practical, workable submission plans; develop and maintain submission timelines; and coordinate internal and external authoring, review, comment adjudication, and finalization through to archival.
  • Deliver accurate and well-reasoned input during regulatory document reviews, ensuring alignment with current regulatory guidance and requirements. ...
Posted
14 days ago
  • Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
  • Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
  • Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups ...
Posted
12 days ago

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

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
  • Develop and maintain strong relationships with internal regulatory teams, affiliates, and distributors to ensure effective stakeholder management and operational excellence.
  • Collaborate with affiliates and distributors to assess the impact of regulatory changes and ensure appropriate follow-up actions are implemented.
  • Drive continuous improvement initiatives and optimize regulatory tools, systems, and ways of working. ...
Posted
6 days ago
  • Strong foundation in Regulatory Affairs, with experience in medical device regulations and registration processes.
  • Proficiency in Regulatory Documentation and Dossier Preparation, including creating, organizing, and updating technical files and submission packages.
  • Knowledge of Regulatory Requirements and Regulatory Compliance, including awareness of relevant Malaysian and international standards and guidelines. ...
Posted
16 days ago
  • 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
  • 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
  • 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
  • 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
  • Regulatory Compliance &amp Product Assessment
  • Conduct regulatory assessments to support product marketing and business decisions across Australia.
  • Prepare and coordinate new substance notifications, inventory update notifications, and exemption permit applications in accordance with local chemical control regulations. ...
Posted
8 days ago
  • Responsible for local regulatory submissions, developing regulatory strategies, and ensuring compliance with applicable laws and regulations.
  • Collaborate with various internal departments and external agencies to achieve regulatory objectives and support business goals.
  • Stay up to date with regulatory changes and maintain positive relationships with regulatory authorities and trade associations. ...
Posted
a month ago
  • Administer regulatory document control systems, ensuring controlled versioning, traceability, and document integrity.
  • Manage regulatory correspondence, authority notices, approvals, conditions, and statutory communications.
  • Maintain structured regulatory registers, licence matrices, approval logs, and authority engagement records. ...
Posted
a month ago
  • Assist in ensuring products comply with applicable Malaysian food regulations and regulatory requirements.
  • Assist in reviewing product formulations and ingredients for regulatory compliance.
  • Assist in checking ingredient specifications, technical documents, COA, MSDS and other supporting documents. ...
Posted
6 days ago
  • Lead the preparation, review, and submission of regulatory dossiers (new registrations, variations, renewals) in compliance with NPRA requirements.
  • Develop and implement regulatory strategies in collaboration with cross-functional teams to ensure timely product approvals and effective life-cycle management.
  • Evaluate and interpret regulatory guidelines and communicate their implications to cross-functional teams, ensuring compliance throughout product development and commercialization. ...
Posted
a month ago