33 Regulatory Affairs Specialist jobs in Malaysia

Key Responsibilities/ Key Activities:

• Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
• Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
• Provides legal and accurate ingredients line and nutrition data for food product labels.
• Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
• Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
• Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
• Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
• Create and review product specifications based on internal specification guidelines.
• Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
• Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

• Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
• Experienced : Minimum at 3 to 5 years’ experience in related field.
• Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
• Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.

Here's how to apply:

• Upload your resume (in English) using our LinkedIn or career site application form
• After applying, we'll reach out within three weeks to let you know what's next.
• During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

Key Responsibilities/ Key Activities:

• Regularly prepares, approves and issues labelling specifications to meet business needs and timelines for the local and foreign markets by following and using effectively JDE & SARA agreed processes and tools.
• Conducts accurate label compliance reviews, such as proposing legal designations and acceptable claims wording, considering local Business requests and legal feedback.
• Provides legal and accurate ingredients line and nutrition data for food product labels.
• Assures implementation of correct graphic design, and able to advise and guide team members on artwork design elements.
• Assures implementation of correct techno-legal label information and JDE standards, e.g. allergen labelling and claims.
• Provides regulatory guidance on compositional requirements to R&D, e.g. checks for acceptable ingredients and their legal limits in recipes.
• Timely reviews and approves new raw materials and product specifications for regulatory compliance in local and other countries, including checking product recipes, nutrition data and allergens information.
• Create and review product specifications based on internal specification guidelines.
• Represents JDE as an expert on local industry associations, scientific institutions and governmental bodies in collaboration with SARA team leads and/or R&D Lead. Identifies, Head of Department and stays abreast of emerging scientific issues and legislation changes.
• Interacts regularly with the other R&D team members, and in particular functional manager, on weekly deliverables.

Are you bursting with fresh ideas and a hunger for learning? We want you!

Here's what we're looking for:

• Academic Program : Degree or Master in Nutrition, Food Chemistry, Food Technology, Food Science or equivalent.
• Experienced : Minimum at 3 to 5 years’ experience in related field.
• Skillset : Possess Knowledge of (EU) food legislation, understanding of nutrition science and food safety, product development, ingredients, manufacturing and business processes.
• Personal traits : You have a structured approach, a driven and energetic personality, excellent communication and people skills, and the ability to work both in a team and independently.

Are you ready to Unleash Your Possibility within JDE Peet's?

Here's how to apply:

• Upload your resume (in English) using our LinkedIn or career site application form.
• After applying, we'll reach out within three weeks to let you know what's next.
• During the application process, you'll be asked to do an online assessment and at least one interview at our Johor office.

Would you like to join a Coffee & Tea company that values your future success and prioritizes your passion for positive change?

Here’s why you should apply:

• Passionate, energetic & innovative work culture.
• Exciting allowances to perk up your day.
• Sports perks to keep you energized.
• The best coffee and tea served all day in our office – or be your own Barista!

For more than 265 years, JACOBS DOUWE EGBERTS (JDE) is inspired by its belief that it’s amazing what can happen over a cup of coffee or tea. We are fuelled by our purpose of unleashing the possibilities of coffee and tea to create a better future. Today, our coffee & tea portfolio is available in more than 100 developed and emerging markets, through a portfolio of over 50 brands that collectively cover the entire category landscape led by leading household names such as L’OR, Jacobs, Senseo, Tassimo, Douwe Egberts, Old Town, Super, Pickwick and Moccona.

JDE is part of JDE Peet’s, the world’s largest pure-play coffee and tea company, headquartered in The Netherlands.

What’s it like to work at JDE?

We are proud of our passionate, driven associates that challenge the status quo and pursue mastery in everything they do. Our goal is simple and ambitious – JDE: A coffee & tea for every cup.

At JDE, we're Made to Stand Out. Every day we are progressive in outlook, ambitious in nature, resourceful in action and decisive in approach, bringing coffee and tea moments to everyone around the world.

Acute Care TechnologyJob Summary:
This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions:

• Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

• Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

• Develop, document, and implement regulatory strategy plans aligned with product development objectives

• Prepare technical dossiers and regulatory submissions for target markets

• Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

• Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

• Implement and maintain standardized submission templates and documentation

• Maintain regulatory files and product licenses in a well-organized and up-to-date manner

• Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

• Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

• Support device recall activities as needed

• Participate in internal audit activities as an auditor

Required Education and Experience:

• Bachelor’s degree in a relevant field

• 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes:

• Strong organizational and time-management skills

• Ability to work independently and collaboratively in a team environment

• Detail-oriented, responsible, and proactive

• Able to perform under pressure and meet deadlines

• Strong written and verbal communication skills

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

Acute Care Technology

Job Summary

This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions

• Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus
• Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements
• Develop, document, and implement regulatory strategy plans aligned with product development objectives
• Prepare technical dossiers and regulatory submissions for target markets
• Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication
• Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards
• Implement and maintain standardized submission templates and documentation
• Maintain regulatory files and product licenses in a well-organized and up-to-date manner
• Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders
• Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy
• Support device recall activities as needed
• Participate in internal audit activities as an auditor
  
  

• Bachelor’s degree in a relevant field
• 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry
  
  

• Strong organizational and time-management skills
• Ability to work independently and collaboratively in a team environment
• Detail-oriented, responsible, and proactive
• Able to perform under pressure and meet deadlines
• Strong written and verbal communication skills
  
  

Senior Regulatory Affairs Specialist, APAC page is loadedSenior Regulatory Affairs Specialist, APAC Apply remote type Hybrid locations Selangor, Malaysia posted on Posted Yesterday job requisition id R15695 Acute Care TechnologyJob Summary:
This position will report to the Senior Manager, Regulatory Affairs Regional Leader, JAPAC. The Primary role of the Specialist within the company is to assist Regulatory Affairs department to implement and administrate of organization activities to support and ensure regulatory compliance.

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You'll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

The Regulatory Affairs Specialist plays a key role in supporting the Regulatory Affairs department by implementing and managing organizational activities to ensure regulatory compliance across key global markets, with a focus on the APAC region.

Essential Functions:

• Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus

• Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements

• Develop, document, and implement regulatory strategy plans aligned with product development objectives

• Prepare technical dossiers and regulatory submissions for target markets

• Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication

• Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards

• Implement and maintain standardized submission templates and documentation

• Maintain regulatory files and product licenses in a well-organized and up-to-date manner

• Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders

• Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy

• Support device recall activities as needed

• Participate in internal audit activities as an auditor

Required Education and Experience:

• Bachelor’s degree in a relevant field

• 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry

Key Skills and Attributes:

• Strong organizational and time-management skills

• Ability to work independently and collaboratively in a team environment

• Detail-oriented, responsible, and proactive

• Able to perform under pressure and meet deadlines

• Strong written and verbal communication skills

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients's lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit

The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit

As a Regulatory Affairs Manager, you will serve as the interface to Regulatory and Global Product Development (GPD) partners within designated Business Units. Your role involves project leadership and expertise in executing regulatory Clinical Trial Applications (CTA) and Central Ethics submissions to regional partners and selected Health Authorities.

You will be responsible for working with business lines to lead operational submission execution for designated CTAs. Acting as a regulatory operational Subject Matter Expert, you will drive submission teams towards the timely delivery of globally compliant, submission-ready documents.

1. Develop and implement global submission management strategies for assigned protocols, collaborating with study teams and managing regulatory activities, standards, and deliverables related to CTA development, including authoring Annex I and related documentation.
2. Participate in relevant meetings to advocate for realistic timelines, understand project strategies, and assess impacts and status of global submission activities.
3. Support and lead efforts to ensure high-quality, compliant submissions aligned with industry, agency, and format guidelines, regulatory strategies, policies, and timelines.
4. Coordinate with Core teams, SSU, Study Management, and relevant suppliers on essential documents for HA and EC submissions and translations.
5. Prepare, review, and support submissions to HA/Regional CTA Hub to secure necessary approvals for clinical trial conduct.
6. Manage translation coordination for core documents required for submissions.
7. Oversee the compilation of core packages, contributing to CTA and documentation authoring as needed.
8. Act as a local country liaison when required.
9. Escalate, inform, and resolve issues impacting submission builds or logistics of global submission delivery to partners or authorities.
10. Collaborate with SMEs to interpret dossier requirements.

1. BSc/B.Sc. in Pharmacy, Life Sciences, or relevant professional experience.
2. Experienced in globally executing Clinical Trial Application and Central Ethics processes.
3. Technically proficient with the ability to quickly adapt to new software, regulations, and standards.

Our success depends on our people. We prioritize building a diverse culture that rewards performance and nurtures talent.

In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible benefits like childcare vouchers, gym discounts, and more

Visit our careers website for more information.

ICON values inclusion & belonging, providing an accessible environment for all applicants. We are committed to equal opportunity employment and offer reasonable accommodations upon request. Learn more about accommodations here .

If you're interested but unsure if you meet all requirements, we encourage you to apply—your skills might be exactly what we're looking for!

As a Regulatory Affairs Manager, you will serve as an interface to Regulatory and Global Product Development (GPD) partners within designated Business Units. Your role involves providing project leadership and expertise in managing the logistics of executing regulatory Clinical Trial Applications and Central Ethics submissions to regional partners and selected Health Authorities.

You will be responsible for collaborating with various business lines to lead operational submission activities for designated Clinical Trial Applications. Acting as a regulatory operational Subject Matter Expert, you will drive submission teams to ensure the timely delivery of globally compliant, submission-ready documents.

What you will be doing:

• Develop and implement global submission management strategies for assigned protocols. Collaborate with study teams to manage regulatory activities, standards, and deliverables related to CTA submission development, including authoring Annex I and related documentation.
• Lead and participate in meetings to advocate for realistic timelines, understand project strategies, assess impacts, and present the status of global submission activities.
• Support and lead efforts to ensure high-quality, compliant submissions that adhere to industry, agency, and format guidelines, regulatory strategies, policies, and timelines.
• Coordinate with Core teams, SSU, Study Management, and relevant suppliers for essential documents and local documentation for HA and EC submissions and translations.
• Prepare, review, and support submissions to HA/Regional CTA Hub to obtain necessary approvals for clinical trial conduct.
• Manage translation coordination for core documents required for submission.
• Oversee the compilation of core packages, contribute to CTA documentation, and author necessary documents.
• Act as a local country liaison when required.
• Escalate, communicate, and resolve issues impacting submission builds or logistics of global submission delivery to regional and local partners or Health Authorities.
• Consult with SMEs on dossier requirements interpretation.

You are:

• Holding a BS/B.Sc in Pharmacy, Life Sciences, or equivalent relevant professional experience.
• Having in-depth understanding and proven experience with Clinical Trial Application and Central Ethics processes globally.
• Possessing technical aptitude with the ability to quickly learn and adapt to new software, regulations, and quality standards.

What ICON can offer you: Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme with TELUS Health
• Life assurance
• Flexible country-specific benefits such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments

Visit our careers website to learn more about working at ICON: . ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and reasonable accommodations for applicants with disabilities. If you need assistance during the application process, please let us know through the provided form: . We encourage you to apply even if you are unsure about meeting all requirements, as you may be the perfect fit for this or other roles at ICON.

Direct message the job poster from Gentle Supreme Sdn Bhd

Job Summary

The Regulatory Affairs Executive plays a key role in ensuring the company’s products and operations comply with regulatory requirements and industry standards. This role includes the preparation of registration dossiers, coordination with authorities, and active support in legal matters such as trademark registration. The position is critical in supporting market access, product compliance, and brand protection.

Key Responsibilities

• Prepare and submit product registration dossiers to relevant regulatory authorities (e.g., NPRA, MOH, MDA) for approval and renewals.
• Monitor and ensure compliance with local and international regulatory requirements.
• Liaise with regulatory agencies, certification bodies, and internal stakeholders to ensure timely approvals and responses to inquiries.
• Maintain updated regulatory documentation, approvals, licenses, and internal tracking systems.
• Support in trademark registration processes, including coordination with legal counsel or trademark agents, submission of applications, renewals, and tracking of status.
• Review and validate product labels, packaging, promotional materials, and technical documents to ensure regulatory compliance.
• Assist in regulatory aspects of new product development, product variation, and post-marketing surveillance.
• Support internal and external audits related to regulatory and compliance matters.
• Stay informed on relevant laws, regulatory changes, and industry updates.
• Prepare periodic reports and summaries for internal use or regulatory submission.

Requirements

• Bachelor’s Degree in Legal, Chemistry, Intellectual Property Law or related discipline.
• 3–4 years of experience in regulatory affairs or compliance roles.
• Familiar with Malaysian regulatory frameworks and agencies such as MOH, NPRA, MDA, and MyIPO (for trademarks).
• Good understanding of regulatory documentation, product registration, and compliance standards.
• Strong attention to detail, analytical, and organizational skills.

• Seniority level Associate

• Employment type Full-time

• Job function Legal and Product Management
• Industries International Trade and Development and Wholesale Import and Export

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