74 Medical Affairs jobs in Malaysia

Purpose

The role aims to ensure the effective, reliable, and current communication of GSK's scientific data through external engagements, assisting healthcare professionals and public health decision-makers in delivering appropriate healthcare solutions to patients. Additionally, it involves providing medical and technical expertise to the medical affairs team, brand team, and other internal partners such as regulatory, strategic development, and marketing.

Key Responsibilities

This role will provide YOU the opportunity to lead key activities as follows:

• Support and enable GSK to achieve its business objectives by delivering ‘in-the-field’ scientific engagement with healthcare professionals and public health decision makers to provide scientific and medical information, identify and manage scientific projects and clinical trial activities, compliantly in line with GSK standard operating procedures and local codes of practice, guidelines and laws

• Gain valuable insight and feedback from the healthcare community on GSK products and services, medical and scientific information which can help guide research, development and service provision to benefit GSK’s customers and patients as well as supporting internal stakeholders

• Responsible of development of Medical Strategic Plan/s, execute Scientific Engagement activities and lead external (customer facing) medical projects for assigned portfolio

• Support Medical Governance (compliance to GSK Code, SAPI Code, and other relevant guidelines) in the assigned portfolio of products and contribute to risk review and management monitoring activities

• Provide medical and technical expertise to scientific submissions, and to marketing & sales in the production, review and approval of promotional materials and activities. Final sign off on allocated promotional materials

• Develop an effective communication network and working relationships with relevant global GSK functions.

• Manage the priorities and workloads.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Degree in Medicine, PharmD or PhD in pharmacy

• Min 6 years of Pharmaceutical or Biotech industry experience (medical affairs, clinical development, or medical research)

• Min 2 years’ experience in hepatology or liver-related disease therapeutic area

• Experience interpreting and communicating scientific data and statistics

• Clear understanding of clinical research methodologies and a demonstrated ability to translate scientific, clinical and safety research studies in an effective credible manner. Able to independently evaluate the literature regarding scientific research

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Ability to maintain a command of a large amount of scientific information across multiple products and decide regarding clinical evidence of importance

• Can understand scientific methods and experimental designs

• Ability to work autonomously and independently with time management skills to effectively manage field-based responsibilities.

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Location:

Kuala Lumpur, MY, MY

Global Business Unit: HEC

Job Function: Client and Customer Services

Requisition Number: 191226

Description:

This is a senior leadership role responsible foroverseeing all Medical and Regulatory Affairs in Southeast Asia. You'll be the strategic leader ensuring our products are supported scientifically and compliantly from start to finish. This means driving strong scientific engagement, ensuring we follow all rules and regulations, and working closely with teams across the company to achieve business goals and ultimately benefit patients. You'll be the key link between our global strategies and what happens on the ground in each country.

• Integrity & Purpose: Lead with strong ethics and a clear sense of direction.

• Strategic & Business Acumen: You can connect medical and regulatory work directly to business goals.

• Scientific & Regulatory Expertise: A strong background in science, a proven track record of compliance, and an innovative mindset in regulatory affairs.

• Market Insight: Deep understanding of healthcare markets and external environments in the region.

• Collaborative Influencer: Skilled at working across complex organizational structures and influencing diverse teams.

• Exceptional Communicator: You can explain complex ideas clearly and build strong relationships.

• Adaptability: Able to lead through change and work effectively across different cultures.

• Talent Developer: Committed to growing and developing your team members.

• Education: An advanced degree in life sciences (like MD, PhD, or similar) is highly preferred.

• Experience: At least 10 years in medical affairs and regulatory affairs within the pharmaceutical or biotech industry. Experience working across multiple countries or regions in a matrix organization is a significant advantage.

We are looking for a dedicated individual to support our Medical Affairs team in ensuring smooth hospital operations, regulatory compliance, and quality patient care.

Key Responsibilities

• Administrative Management: Oversee daily administrative and operational activities for department efficiency.
• Medical Affairs Support: Assist in the recruitment, onboarding, credentialing, and privileging of medical practitioners. Maintain contractual agreements and coordinate on-call rosters.
• Clinical Risk Management: Help develop and implement hospital risk management frameworks, investigate incidents, and support quality improvement initiatives to enhance patient safety.
• Regulatory Compliance & Liaison with Authorities: Ensure compliance with all relevant healthcare regulations, including the Private Healthcare Facilities and Services Act (PHFSA) 1998, MMC Guidelines, and Personal Data Protection Act. Assist in licensing processes, coordinate with medical agencies and authorities for hospital facility expansions, and ensure mandatory reporting is conducted efficiently.
• Secretariat Duties:
• Arrange, coordinate, and document meetings for the Medical Advisory Committee (MAC), MAC Subcommittees, and Hospital Committees.
• Prepare agendas, compile meeting materials, and ensure timely distribution to relevant stakeholders.
• Accurately record minutes of meetings, capturing key discussions, decisions, and action points.
• Follow up on action items to ensure implementation and compliance with hospital governance policies.
• Maintain well-organized and secure records of all committee documentation, reports, and meeting proceedings.
• Liaise with the Person in Charge (PIC) and MAC Chairman to ensure clinical governance policies and best practices are upheld.
• General Administration: Liaise with key personnel to uphold clinical governance policies and manage office requisitions.

Qualifications & Experience

• Candidate with Degree in Medicine (MBBS) is preferred.
• Minimum 3 – 4 years healthcare industry experience.
• Proficient in the use of Microsoft Office Software
• A strong administrative background, preferably in healthcare.
• Excellent coordination, organizational, and problem-solving skills.
• Familiarity with hospital regulations and medical practitioner documentation is a must.
• Experience in liaising with medical agencies, regulatory bodies, and healthcare authorities.
• Strong communication skills and attention to detail, particularly in secretarial and governance-related responsibilities.
• Ability to work with multiple stakeholders and ensure compliance with best practices.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Position Based in Malaysia

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about improving the lives of patients’ and are bold in both decision and action. We believe that partnering with health systems around the world can create value for patients, society and for Roche. We are uniquely positioned to realize truly integrated health solutions across pharmaceuticals, diagnostics, digital health and big data solutions; positioning us as a key partner for personalized, sustainable healthcare everywhere.

The Medical Affairs Partner (MAP) demonstrates personal purpose around improving the patient journey, as well as strong passion to create value and impact on the ecosystem. The MAP is a senior level role within the affiliate, who has decision making authority to request resources of Roche (both within the affiliate and broader network) in order to have improved impact on the patient journey.
They are a core member of the disease area pod working in close collaboration with the Patient Journey Partners (PJP). The MAP spends majority of their time in the field close to customers communicating the value of Roche's science and products to physicians, investigators and institutions. They think from an enterprise level, and will also be a member of an APAC level network working across borders, to realize and scale country outcomes by contributing to virtual, cross border, cross functional work package teams.

The Opportunity:
The Medical Affairs Partner has a reporting line to the Country Medical, Innovation and Regulatory Lead, serves the affiliate vision with an aligned mindset and behaviors.

• Oversee the patient journey in its entirety, acts as a system thinker with the ability to identify shared purpose among stakeholders and cocreate with them to bring better outcomes for patients faster by translating insights into strategic and actionable recommendations.

• Bring the inside out, to bring Roche expertise, science and knowledge to the ecosystem. Steward Roche’s products through their lifecycle and supports their appropriate use, which includes sharing their merits with Healthcare Professionals (HCPs) in a truthful and balanced manner. Ensure great experiences whenever stakeholders in the ecosystem engage with Roche employees, products and services.

• Pull in expertise and resources locally and from the network as needed, prioritize and drive solutions that deliver outcomes faster. Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value.

• Identify important data gaps and opportunities designing and supporting data generation plans to address them including phase IV studies, registries and real world evidence generation.

• Hold an altruistic approach in supporting the global network.

• Act as a leader, coach and mentor, who supports team working and actively contributes to the learning & development of peers across strategically aligned therapy areas, key medical affairs capabilities and engagement with healthcare professionals and patient groups.

• Display integrity in all levels (i.e. open, honest, ethical and genuine). All Roche employees are expected to practice high standards of compliance with both external and internal policies and regulations as well as participate and be involved in SHE initiatives within the Company.

Who You Are:

• Is self-managed and self-directed, ready to take on empowerment. Demonstrates a growth mindset, able to learn and unlearn quickly, take risks and experiment.

• Has an enabler mindset leveraging the internal and external networks to create value, sharing back and scaling. Has outstanding partnering capabilities such as coaching, consulting, ability to
  listen deeply, question and understand.

• Willing to travel when needed.

Skills and Experience :

• Has a deep understanding of patient journey and related treatments, medical affairs strategies & tactics including clinical research as well as broad understanding of Roche’s present portfolio and future pipeline, such that they can work on future-based solutions. Is able to effectively share scientific information including investigational findings through direct communications and engagement at scientific conferences with healthcare professionals and/or the scientific community.

• Has excellent stakeholder engagement skills including partnering with Therapeutic Area Experts (TAEs) and organizations is required. Experience partnering with Patient Advocacy Group
  (PAGs) is highly desired.

• Evidence generation skills is required. Supports relevant Product Development Medical Affairs (Global Medical Affairs) (PDMA) and Country Clinical Operations trial, Early Access Program and Compassionate Use program activities within their disease area/ecosystem

• Work efficiently and harmoniously in a cross-functional team, able to formulate cross-functional strategies and orchestrate cross-functional teams. Experience in agile ways of working is highly desired.

• Experience with medical review of promotional materials is required.

• Ability to leverage digital means and tools is required.

• Proficiency in English is required, fluency in the local language is desired.

Education & Expertise:

• Medical degree and/or PHD preferred, bachelor’s degree in life sciences (eg. immunology, biomedical, biology or pharmacy) required.

• Minimum of 3 years experience within a Medical Affairs role in Pharmaceutical, Diagnostics, Health Sciences, Biotechnology or other related fields is required.

• Experience and expertise in Ophthalmology , specifically retinal diseases such as Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) is preferred. Open to those with other TA experiences as well.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about improving the lives of patients’ and are bold in both decision and action. We believe that partnering with health systems around the world can create value for patients, society and for Roche. We are uniquely positioned to realize truly integrated health solutions across pharmaceuticals, diagnostics, digital health and big data solutions; positioning us as a key partner for personalized, sustainable healthcare everywhere.

The Medical Affairs Partner (MAP) demonstrates personal purpose around improving the patient journey, as well as strong passion to create value and impact on the ecosystem. The MAP is a senior level role within the affiliate, who has decision making authority to request resources of Roche (both within the affiliate and broader network) in order to have improved impact on the patient journey.
They are a core member of the disease area pod working in close collaboration with the Patient Journey Partners (PJP). The MAP spends majority of their time in the field close to customers communicating the value of Roche's science and products to physicians, investigators and institutions. They think from an enterprise level, and will also be a member of an APAC level network working across borders, to realize and scale country outcomes by contributing to virtual, cross border, cross functional work package teams.

The Opportunity:
The Medical Affairs Partner has a reporting line to the Country Medical, Innovation and Regulatory Lead, serves the affiliate vision with an aligned mindset and behaviors.

• Oversee the patient journey in its entirety, acts as a system thinker with the ability to identify shared purpose among stakeholders and cocreate with them to bring better outcomes for patients faster by translating insights into strategic and actionable recommendations.

• Bring the inside out, to bring Roche expertise, science and knowledge to the ecosystem. Steward Roche’s products through their lifecycle and supports their appropriate use, which includes sharing their merits with Healthcare Professionals (HCPs) in a truthful and balanced manner. Ensure great experiences whenever stakeholders in the ecosystem engage with Roche employees, products and services.

• Pull in expertise and resources locally and from the network as needed, prioritize and drive solutions that deliver outcomes faster. Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value.

• Identify important data gaps and opportunities designing and supporting data generation plans to address them including phase IV studies, registries and real world evidence generation.

• Hold an altruistic approach in supporting the global network.

• Act as a leader, coach and mentor, who supports team working and actively contributes to the learning & development of peers across strategically aligned therapy areas, key medical affairs capabilities and engagement with healthcare professionals and patient groups.

• Display integrity in all levels (i.e. open, honest, ethical and genuine). All Roche employees are expected to practice high standards of compliance with both external and internal policies andregulations as well as participate and be involved in SHE initiatives within the Company.

Who You Are:

• Is self-managed and self-directed, ready to take on empowerment. Demonstrates a growth mindset, able to learn and unlearn quickly, take risks and experiment.

• Has an enabler mindset leveraging the internal and external networks to create value, sharing back and scaling. Has outstanding partnering capabilities such as coaching, consulting, ability to
  listen deeply, question and understand.

• Willing to travel when needed.

Skills and Experience :

• Has a deep understanding of patient journey and related treatments, medical affairs strategies & tactics including clinical research as well as broad understanding of Roche’s present portfolio andfuture pipeline, such that they can work on future-based solutions. Is able to effectively sharescientific information including investigational findings through direct communications andengagement at scientific conferences with healthcare professionals and/or the scientific community.

• Has excellent stakeholder engagement skills including partnering with Therapeutic Area Experts (TAEs) and organizations isrequired. Experience partnering with Patient Advocacy Group
  (PAGs) is highly desired.

• Evidence generation skills is required. Supports relevant Product Development Medical Affairs (Global Medical Affairs) (PDMA) and Country Clinical Operationstrial, Early Access Program and Compassionate Use program activities within their diseasearea/ecosystem

• Work efficiently and harmoniously in a cross-functional team, able to formulate cross-functionalstrategies and orchestrate cross-functional teams. Experience in agile ways of working is highlydesired.

• Experience with medical review of promotional materials is required.

• Ability to leverage digital means and tools is required.

• Proficiency in English is required, fluency in the local language is desired.

Education & Expertise:

• Medical degree and/or PHD preferred, bachelor’s degree in life sciences (eg. immunology,biomedical, biology or pharmacy) required.

• Minimum of 3 years experience within a Medical Affairs role in Pharmaceutical, Diagnostics,Health Sciences, Biotechnology or other related fields is required.

• Experience and expertise in Ophthalmology , specifically retinal diseases such as Neovascular Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)is strongly preferred.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

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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