What Jobs are available for Customs Regulations in Malaysia?

Senior HR Executive | Payroll Management | Detail-Oriented Job Description

Plan, prepare and submit product registration application (new, renewal & variation) to competent authorities in Malaysia and other countries where the company is exporting to.

Follow up on registration applications with relevant authorities and business partners.

Gathering, collating and evaluating a wide range of information via references and various media inclusive the internet.

Collecting, coordinate, evaluating and compile data and documents in a variety of format.

Liaising and negotiating with government agencies and business partners.

Keeping abreast of local and international legislation, guidelines and practices.

Providing advice to other departments as appropriate.

Job Requirement

Self‑discipline and sense of duty, strictly adhere to company policies, administrative procedures and code of conduct.

Degree in pharmacy, biomedical sciences, biochemistry, biotechnology or relevant science field.

Good interpersonal and computer skills.

Self‑motivated with strong initiative and able to work independently in a challenging environment.

Able to prioritise and organise workload, adapting to fit the changing needs of the business.

Able to converse in Bahasa Malaysia and English.

Strong team‑working skills and able to communicate clearly and effectively, verbally and in writing.

Experience in product registration/ regulatory affairs and knowledge in pharmaceuticals (New Drug Product) would be an advantage.

Seniority level Executive

Employment type Full‑time

Job function Science, Product Management, and Research

Industries Pharmaceutical Manufacturing

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Regulatory Affairs Specialist – Onsite– Malaysia (Fixed-term 2 years)

We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve.

Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting.

The Regulatory Affairs Specialist in this position is responsible assisting with implementation of regulatory strategies including domestic and international submissions and other support of product project team.

Key Responsibilities

Position will primarily serve as a liaison between Malaysia plant personnel and UCC Design Center RA with full oversight from UCC Design Center RA Department. All work, assessments and materials will be approved by Design Center RA.

May provide assessment for plant changes with oversight and approval of assessment by Design Center RA.

Assist in providing regulatory support through the product life cycle on product project teams under supervision of Design Center RA.

Assist in the provision of international submissions as assigned by Design Center.

Assist in providing support for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations as assigned by Design Center.

Other project assessments as assigned by Design Center RA.

Education and Experience required

BS in a scientific discipline with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalent.

Must be able to maintain confidentiality in dealing with regulatory and clinical documentation.

Must have excellent written and verbal communication skills.

Must be self‑motivated and have the ability to take ownership of her/his responsibilities.

Must be able to prioritize and handle several projects concurrently.

Must have technical writing skills and be proficient at compiling thorough regulatory change assessments describing change impacts on finished device safety and effectiveness.

Education and Experience preferred

Knowledge of the U.S. and European medical device regulations required.

Benefits Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth‑centered, and rewarding culture.

You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization’s investment in BD University, you will continually level up your tech skills and expertise.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.

At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

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Regulatory Affairs Associate Bayer – Kuala Lumpur, Malaysia.

Overview Primarily focused on regulatory compliance and milestone delivery for the Bayer portfolios in Malaysia & Brunei. Responsible for ensuring regulatory compliance and meeting local regulatory milestones for a designated range of products. Oversee electronic and paper archiving systems, manage product lifecycles, update regulatory databases, and facilitate communication with stakeholders.

Key Responsibilities

Ensure local regulatory compliance through the preparation and submission of timely, high-quality documentation for labeling updates, license renewals, and other required applications.

Monitor submission status and support timely responses to deficiency letters and regulatory authority requests, ensuring accurate documentation of all interactions.

Maintain and update internal and external regulatory databases, providing relevant milestones and updates to cross‑functional teams.

Oversee the implementation of approved labeling into packaging materials, in compliance with local legislation and company SOPs.

Collaborate with internal stakeholders to collect and validate information required for regulatory submissions, ensuring alignment with business needs.

Ensure regulatory compliance of product registrations, labeling, and promotional materials, in line with local health authority requirements and company policies.

Review labels, artwork, promotional materials for compliance.

Maintain regulatory documentation, licensing, and filing systems.

Key Skills & Qualifications

Educational background in a related field such as pharmacy, life sciences, or pharmaceuticals.

Strong understanding of regulatory requirements and processes.

Excellent communication for liaising with regulatory agencies, internal and external stakeholders.

Attention to detail and accuracy in documentation and compliance procedures.

Strong organization, communication, and stakeholder management skills.

Analytical and problem‑solving skills for resolving regulatory issues and challenges.

Project management skills to coordinate regulatory activities and timelines effectively.

Knowledge of relevant guidelines, industry standards, and policies.

Application Period & Reference Code Application Period: 20 August 2025 – 28 August 2025. Reference Code: 85182.

Position Details Division: Consumer Health Location: Petaling Jaya, Selangor, Malaysia Functional Area: Regulatory Affairs Position Grade: E11.

Employment Type Full Time; Work Time: 9:00 am – 6:00 pm.

Contact Contact Email:

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Overview

Are you looking to grow your career in Regulatory Affairs and make an impact in the development of new medicines? We’re seeking a Regulatory Affairs Consultant to support global and local regulatory projects, providing scientific and strategic input throughout the product development lifecycle. This role offers an exciting opportunity to work closely with experienced consultants, clients, and project teams—developing hands-on expertise in regulatory submissions, strategy, and client communication. What You’ll Do

Support and coordinate regulatory consulting projects, including CTD authoring, document preparation, country submissions, gap analysis, and regulatory strategy. Collaborate with senior consultants to provide high-quality regulatory insights and ensure projects are delivered on time and meet client expectations. Conduct research and apply relevant guidelines (ICH and local regulations) to support client projects. Participate in client discussions, project scoping, and proposal preparation. Contribute to continuous improvement of tools and processes that enhance project quality and efficiency. Learn from and be mentored by senior regulatory professionals to develop your consulting and project management skills. What You’ll Bring

2–6 years of experience in Regulatory Affairs, the pharmaceutical industry, or clinical research. Strong understanding of ICH guidelines and local regulatory requirements. Excellent communication, organisation, and problem-solving skills. Ability to work effectively in a cross-functional and multicultural team environment. Bachelor’s degree or above in life sciences, pharmacy, medicine, or a related field (e.g., pharmacology, molecular biology, chemical engineering). Pharmacist licence preferred. Bilingual proficiency in English and Chinese (written and spoken) highly desirable. Why Join Us

You’ll join our brand new office in Malaysia and be part of a supportive and collaborative global team, working on diverse projects that shape the future of drug development and healthcare. We offer opportunities for professional growth, mentorship, and ongoing development within an international regulatory environment. Apply

Apply today to take the next step in your Regulatory Affairs career and help bring innovative therapies to patients worldwide. Seniority level

Associate Employment type

Full-time Job function

Project Management and Research Industries

Biotechnology Research and Research Services

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Head of Human Resources at Gentle Supreme

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.

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Regulatory Affairs Manager page is loaded# Regulatory Affairs Managerlocations:

Malaysia, Petaling Jayatime type:

Full timeposted on:

Posted Todaytime left to apply:

End Date: December 31, 2025 (30+ days left to apply)job requisition id:

R-94910At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Manage regulatory operational and technical aspects on company’s behalf for the business partners who are marketing authorization holders:* Align on submission plans, monitor progress and provide support as necessary* Ensure timely provision of required submission dossiers to business partners* Foster an environment of operational excellence and liaise cross-functionally on regulatory strategy* Oversee labelling projects to ensure new and updated labelling are implemented timely**Business Partner Collaboration and Oversight*** Build and maintain strong working relationships with business partners* Follow-up on application progress and periodically review business partner performance metrics* Serve as regulatory point person for any regulatory queries from internal and external stakeholders* Ensure business contracts are current and valid* Responsible for the execution of third party management activities* Coach Regulatory Associates on third party oversight and establish metrics**Regulatory Planning*** Collaborate with business partners to ensure timely and clear dossier requirements during submission planning* Liaise cross-functionally with internal and external stakeholders to agree on regulatory strategy* Facilitate implementation of the regulatory plan

**Dossier Management*** Obtain all required submission documents and ensure timely responses to Regulatory Authority requests* Ensure documents meet requirements or use regulatory expertise to provide creative solutions if unable to meet requirements* Ensure provision of submission documents to business partner per contract timelines* Ensure archiving of electronic copies of applications**Regulatory Compliance*** Ensure data maintenance and data integrity of regulatory systems with defined compliance metrics* Ensure implementation of local quality system in line with the global quality system* Ensure audit and inspections readiness* Effective issue management and implement corrective/preventive actions as appropriate**Labelling*** Perform the role of a labelling responsible person* Ensuring that product information complies with company core data sheet* Liase with stakeholders to ensure timely implementation of label changes**Process Improvement*** Ensure alignment and implementation of internal regulatory initiatives**Minimum Qualification Requirements:*** Bachelor's degree or equivalent in a relevant scientific subject* Team working skills with special focus on results* Ability to adapt to challenging situations* Demonstrated good computer/IT skills* Good knowledge of written and spoken English* Analytical, problem solving and negotiation skills* Good communication skills* Project management skills* Strong knowledge of quality systemsLilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form () for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLillyAt Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.

We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #J-18808-Ljbffr

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Manage regulatory operational and technical aspects on company’s behalf for the business partners who are marketing authorization holders:

Align on submission plans, monitor progress and provide support as necessary

Ensure timely provision of required submission dossiers to business partners

Foster an environment of operational excellence and liaise cross-functionally on regulatory strategy

Oversee labelling projects to ensure new and updated labelling are implemented timely

Business Partner Collaboration and Oversight

Build and maintain strong working relationships with business partners

Follow-up on application progress and periodically review business partner performance metrics

Serve as regulatory point person for any regulatory queries from internal and external stakeholders

Ensure business contracts are current and valid

Responsible for the execution of third party management activities

Coach Regulatory Associates on third party oversight and establish metrics

Regulatory Planning

Collaborate with business partners to ensure timely and clear dossier requirements during submission planning

Liaise cross-functionally with internal and external stakeholders to agree on regulatory strategy

Facilitate implementation of the regulatory plan

Dossier Management

Obtain all required submission documents and ensure timely responses to Regulatory Authority requests

Ensure documents meet requirements or use regulatory expertise to provide creative solutions if unable to meet requirements

Ensure provision of submission documents to business partner per contract timelines

Ensure archiving of electronic copies of applications

Regulatory Compliance

Ensure data maintenance and data integrity of regulatory systems with defined compliance metrics

Ensure implementation of local quality system in line with the global quality system

Ensure audit and inspections readiness

Effective issue management and implement corrective/preventive actions as appropriate

Labelling

Perform the role of a labelling responsible person

Ensuring that product information complies with company core data sheet

Liase with stakeholders to ensure timely implementation of label changes

Process Improvement

Ensure alignment and implementation of internal regulatory initiatives

Minimum Qualification Requirements

Bachelor's degree or equivalent in a relevant scientific subject

Team working skills with special focus on results

Ability to adapt to challenging situations

Demonstrated good computer/IT skills

Good knowledge of written and spoken English

Analytical, problem solving and negotiation skills

Good communication skills

Project management skills

Strong knowledge of quality systems

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

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Senior Regulatory Affairs Wellous Group WP, Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from Wellous Group.

Job Descriptions:

Manage the end-to-end process of product registration, notification, and renewal with regulatory authorities in Malaysia and international markets.

To be well versed with the requirement and development as well as follow up on any local food regulatory licenses and applications including but not limited to HALAL, HACCP and so on for the group of companies.

Lead regulatory efforts to expand the company’s presence in new overseas markets.

Manage the company’s trademarks across all relevant countries, ensuring timely registrations, renewals, and protection against potential infringements.

Act as the main liaison with Malaysia and international markets’ regulatory bodies (e.g., NPRA, FSQD, customs) to resolve non-compliance warnings and complaints.

Lead proactive initiatives to update product labels in response to new regulations or market-specific requirements.

Provide regulatory advice and support to internal teams, including R&D, marketing, corporate branding, and compliance.

Monitor regulatory updates and communicate changes to ensure product compliance with new or revised standards.

Maintain and update regulatory files, including Product Information Files (PIF) and other required records, for internal and external audits.

Perform ad hoc duties as assigned by superior from time to time.

Requirements:

Minimum of 3 years’ experience in regulatory affairs, preferably within the food or health supplement industry.

In-depth knowledge of Malaysian and international regulatory requirements for food and health supplement products.

Proficiency in English, Mandarin, and Bahasa Malaysia to effectively communicate with regulatory authorities and stakeholders.

Strong interpersonal and communication skills to collaborate with internal teams and external consultants.

Ability to stay updated with regulatory changes and adapt to evolving market needs.

Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

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SUN PHARMA WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia Regulatory Affairs Executive

To ensure compliance with national and international regulatory requirements by preparing, reviewing, and submitting product registration dossiers and variations, while supporting cross-functional teams in maintaining product quality, safety, and efficacy. Key Responsibilities : Regulatory Submission & Compliance Prepare, compile, and submit product registration dossiers to regulatory authorities (e.g., NPRA and HSA) within stipulated timelines. Handle applications for new registrations, renewals, variations, and post-approval commitments. Maintain regulatory databases and tracking systems to ensure up-to-date product status. Documentation & Review Review and ensure accuracy of product labeling, artwork, packaging, and promotional materials in compliance with regulatory guidelines. Maintain and update regulatory files, records, and product dossiers. Review technical documents (e.g., CMC, stability data, clinical reports) to ensure regulatory compliance. Monitor and interpret changes in local and international regulations, guidelines, and standards. Provide regulatory guidance to internal teams (R&D, QA/QC, Production, Marketing). Act as a point of contact between the company and regulatory authorities. Coordinate with external stakeholders (regulatory consultants, partners, contract manufacturers). Support audits and inspections by health authorities. Cross-Functional Support Work closely with Quality Assurance (QA) and Quality Control (QC) to ensure compliance with GMP and GDP. Support product lifecycle management and regulatory strategy for new product development. Cross-functional communication to ensure smooth regulatory submissions and compliance. Job Requirements : Bachelor’s degree in Pharmacy or a related field (e.g., BPharm, PharmD)/ Biomedical Sc./Other health Life sciences/Science). Familiar with NPRA, HSA, ASEAN, ICH guidelines. Proficiency in managing regulatory databases and tools. Knowledge of adverse event reporting systems and safety databases. Ability to review and manage regulatory and safety documents with precision. Strong ability to liaise with regulatory authorities, internal teams, and external stakeholders. Seniority level

Associate Employment type

Full-time Job function

Business Development and Sales Pharmaceutical Manufacturing

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