Halal Certification Management
Research and Development (R&D)
Food Science
Product Development
Quality Assurance
Regulatory Affairs
Food Safety Standards
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)....
Administrative Support
Scheduling
Communication
Record Keeping
Executive Assistance
Time Management
Organization
Problem Solving
Attention to Detail
Office Management
Halal Certification Management
Research and Development (R&D)
Food Science
Product Development
Quality Assurance
Regulatory Affairs
Food Safety Standards
Halal Certification Management
Research and Development (R&D)
Food Science
Product Development
Quality Assurance
Regulatory Affairs
Food Safety Standards
Halal Certification Management
Research and Development (R&D)
Food Science
Product Development
Quality Assurance
Regulatory Affairs
Food Safety Standards
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....
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....
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....
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....
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....
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....
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....
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....
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...
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....
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....
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....
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....
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....
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....
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....
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....
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....
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....