Assist in compiling and organizing documents required for product registration/information (e.g. MoH Food & Pharma. Div., RMCD, DOSH etc).
Review and validate product labels, packaging, promotional materials, and technical documents from regulatory perspective to ensure regulatory compliance.
Help translate or format technical documents when necessary.
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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.
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Be responsible for and follow the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives
Ensure compliance, monitor, and update changes related to regulations set by local Regulatory Agencies and support the Head of Regulatory Affairs on other regulatory affairs matter when necessary
Ensure continuous knowledge update on the registration process for Pharmaceuticals, Biotech, Health Supplements, Generics, Medical Device, Veterinary and Cosmetics in Malaysia
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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.
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Be responsible for and follow the agreed plan and timelines for Registration Projects to meet client and internal stakeholder objectives
Ensure compliance, monitor, and update changes related to regulations set by local Regulatory Agencies and support the Head of Regulatory Affairs on other regulatory affairs matter when necessary
Ensure continuous knowledge update on the registration process for Pharmaceuticals, Biotech, Health Supplements, Generics, Medical Device, Veterinary and Cosmetics in Malaysia
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We are a leading manufacturer of health supplement products dedicated to providing high-quality formulations that meet regulatory standards. We are seeking a detail-oriented and proactive Regulatory Affairs and Technical Executive to join our team
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.
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To support the Superior in regulatory, statutory, and Quality Management System (QMS) requirements matters.
Support to develop, register, facilitate, and maintain all regulatory submissions related to establishment and product registration with applicable Regulatory Authority.
Support and assist in liaising with regulatory authorities, designated agents, and notified bodies on all regulatory-related matters.
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