63 Clinical Affairs jobs in Malaysia

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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We're Hiring: Manager Regulatory Affairs!

We are seeking an experienced and detail-oriented Manager Regulatory Affairs to lead our regulatory compliance initiatives and ensure adherence to all applicable laws and regulations. The ideal candidate will have extensive knowledge of regulatory frameworks, excellent analytical skills, and the ability to navigate complex regulatory environments while supporting business objectives.

Location: Kuala Lumpur, Malaysia

Work Mode: Work From Office

Role: Manager Regulatory Affairs

What You'll Do

Develop and implement comprehensive regulatory compliance strategies

Monitor regulatory changes and assess impact on business operations

Prepare and submit regulatory filings and documentation

Liaise with regulatory authorities and government agencies

Conduct regulatory risk assessments and audits

Provide regulatory guidance to cross-functional teams

What We're Looking For

Bachelor's degree in Law, Life Sciences, or related field

5+ years of regulatory affairs experience

Strong knowledge of Malaysian regulatory landscape

Excellent written and verbal communication skills

Detail-oriented with strong analytical abilities

Experience with regulatory submissions and compliance management

Ready to make an impact? Apply now and let's grow together!

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Other
• Industries IT Services and IT Consulting

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Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 week ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 days ago

Federal Territory of Kuala Lumpur, Malaysia 4 days ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 3 weeks ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 1 month ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 2 weeks ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 15 hours ago

WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 7 months ago

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 11 months ago

Federal Territory of Kuala Lumpur, Malaysia 1 week ago

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Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia 4 days ago

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Job Responsibilities:

1. Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
2. Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
3. Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
4. Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
5. Prepare and submit scientific and technical documentation for special projects or novel product classifications.
6. Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
7. Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
8. Undertake any additional regulatory tasks or projects as assigned by the management team.

Job Requirements:

1. A Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
2. Minimum 2 years of hands-on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
3. Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
4. Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
5. Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
6. Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.

• Asist in product registration, notification, and renewal with regulatory authorities for both Malaysia and international market.
• Monitor regulatory updates and changes, to ensure product compliance with new or revised standards.
• Review, amend, approve all product labels and packaging artwork to ensure compliance with regulatory and company standards.
• Maintain and update regulatory documents and records for internal and external audits.
• Support KKLIU advertisement submissions and handle food labelling screening submissions in Food Safety & Quality Division
• Handle application for Certificate of Declaration, Certificate of Indication, Certificate of Free Sales, and Certification of Pharmaceutical Product.
• Perform ad hoc duties as assigned by superior from time to time.
  
  

• Bachelor's in any science discipline, food science or related fields.
• 1-2 years of experience in regulatory affairs or quality assurance, preferably within the food, TMHS or personal care industry.
• Good knowledge of Malaysian regulatory guideline (eg. DRGD, Food Act 1983 etc) and international regulatory guidelines (eg. ASEAN, EU, USFDA etc)
• Familiar with QUEST3+, FOSIM, eHalal.
• Proficient in English and Mandarin.
  
  

• EPF
• EIS
• SOCSO
• Annual and Medical Leave

JOB PURPOSE

The Regulatory Affairs Officer is responsible for supporting the product registration process primarily within Hong Kong and Singapore, ensuring compliance with regulatory requirements and facilitating timely approvals. This role involves coordinating with various external parties such as regulatory authorities, third party agents, business partners, and conformity assessment bodies (CAB); preparing and submitting documentation, and collaborating with internal teams to ensure adherence to local and international regulations.

By maintaining up-to-date knowledge of regulatory changes, the Regulatory Affairs Officer plays a key role in ensuring product approval with the health authorities.

DUTIES AND RESPONSIBILITIES

1. Ensuring compliance with local and international regulatory requirements for products and services.
2. Communicating with business partners to gather documents required for product registration within the required time frame.
3. Reviewing and analyzing business partner’s documents, using a number of different methods including artificial intelligence (AI), for product registration in compliance with applicable regulations.
4. Preparing, submitting, and managing regulatory filings, including applications, renewals, and changes.
5. Collaborating with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards.
6. Monitoring and interpreting changes in regulations to advise the company on necessary adjustments.
7. Communicating with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance.
8. Maintaining accurate documentation and records to support audits and inspections.
9. Providing guidance and training to teams on regulatory requirements and best practices.
10. Addressing regulatory inquiries and supporting risk management initiatives.

WORKING CONDITIONS

The Regulatory Affairs Officer will work in a hybrid environment, splitting time between remote work and in-office duties, as determined by your manager. The individual will be based in Malaysia and will collaborate with local and international teams.

SKILLS & QUALIFICATIONS

Education : Bachelor’s degree in medical, science or business-related discipline.
Experience : Minimum of 2 years of combined experience in Regulatory Affairs, preferably with exposure to the healthcare or medical device industry.
Skills :
1. Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders.

2.Highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments.
3.Well-organized and capable of managing multiple regulatory processes efficiently.
4.Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions.
5.Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment.
6.Familiarity with relevant regulatory frameworks and digital tools e.g. AI, SharePoint, etc. for documentation management.
7.Handling electronic submissions and regulatory databases.
Business Understanding : Strong knowledge of licensing and product registration processes and overall regulatory compliance

Job Description & Requirements

Reporting to the Regulatory Affairs Manager, you will be responsible for assisting in Regulatory Affairs activities for clinical trials and marketing authorisation.

Responsibilities

· Assist with submission of applications and variations for clinical trials and marketing authorisation across all pipelines

· Support regulatory assessment of submission requirements based on relevant regulations

· Assist with administrative work necessary to support regulatory activities

· Review and provide input for regulatory documents

· Support any other duties assigned

Qualifications

· Degree in Biological, Chemistry, or a related field

· No experience required. Must have an interest in Regulatory Affairs

· Keen learner with a strong attention to detail and organizational skills

· Proficiency in English (written and spoken) is required