137 Regulatory Affairs jobs in Malaysia

Overview

Manager, Regulatory Affairs — TNG Digital WP. Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Job Brief

As the Manager of Regulatory Affairs, you will assist the Senior Manager in overseeing the company’s compliance efforts, working closely with stakeholders to develop, implement, and maintain compliance programs aligned with legal, regulatory, and industry standards, both locally and globally. You will work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution, while focusing on managing day-to-day operations of the regulatory affairs functions within the company and ensuring compliance with existing regulations and standards.

Responsibilities

• Assist in the development and implementation of regulatory compliance strategies and policies to align with company objectives and regulatory requirements, in Malaysia and globally.
• Monitor, analyse, and interpret regulatory updates from relevant authorities and advise business units on compliance with regulatory frameworks.
• Review and provide feedback on regulatory consultation papers, exposure drafts, and other legislative documents issued by Malaysian authorities.
• Manage regulatory related applications, submissions and reporting, ensuring compliance with approval requirements, deadlines, and policies.
• Lead the development and implementation of automated compliance processes, including reporting, approvals, and monitoring to improve operational efficiency.
• Monitor and track regulatory filings and approvals to ensure timely, accurate submissions and adherence to relevant requirements.
• Maintain an organized and up-to-date library of compliance documentation, including approvals, submissions, and correspondence.
• Stay informed on changes in laws, regulations, and industry standards, and update compliance programs as necessary and ensure the company’s licensing strategy aligns with these changes.
• Identify areas of improvement and recommend corrective actions to ensure compliance.
• Collaborate with cross-functional teams to provide regulatory guidance in product development, marketing, and operations.
• Serve as the secondary point of contact for regulatory authorities and external auditors, ensuring timely, accurate responses.
• Assist in the development and delivery of training on compliance policies and regulatory requirements.
• Build and maintain relationships with key stakeholders, including regulatory authorities, industry associations, and legal counsel.
• Prepare reports and or presentations for senior management on regulatory compliance activities, issues, and emerging trends.
• Provide concise and actionable insights and advice to stakeholders based on compliance requirements, records and regulatory updates.

Qualifications

• Bachelor's degree in business, law, finance, or a related field. An advanced degree is preferred.
• Ideally, 6 or more years of experience in regulatory affairs or a related field within the payments or financial services industry.
• Strong understanding of regulatory frameworks with the ability to interpret and apply complex legal and regulatory requirements to business operations.
• Proficient in leveraging data analysis software and AI tools to enhance operational efficiency and ensure accurate compliance management.
• Skilled in analysing complex proposals and developing actionable recommendations, using data and inputs from multiple stakeholders to support conclusions.
• Manage a variety of viewpoints to build consensus and create positive outcomes for all stakeholders.
• Ability to distil complex messages, simplifying key points for diverse audiences.
• Detail-oriented with proficiency in managing regulatory submissions, reporting, and compliance documentation, ensuring accuracy and timeliness in meeting legal and policy requirements.
• Strong analytical skills to assess regulatory risks and implement effective compliance strategies.
• Excellent communication skills (written and verbal), including the ability to negotiate, influence regulatory changes, and manage stakeholder relationships.
• Exceptional organizational and project management skills with the ability to prioritize tasks and manage multiple deadlines in a fast-paced environment.
• Proven ability to collaborate with cross-functional teams, providing guidance on regulatory matters in product development, marketing, and operations.
• Uphold the firm's code of ethics and business conduct.
• Flexi working hours.
• Monthly eWallet allowance.
• Additional 1% employer EPF contribution from your 1st to 3rd year of service, with further increases based on your continued years of service.
• Unlimited office pantry fruits, snacks and drinks.
• Mobile and broadband subscription reimbursement.
• Flexibility to opt dependants coverage (spouse, child, parents or parents-in-law) for outpatient medical benefits.
• Additional leave including family leave and paid care leave to care for family members.
• Medical coverage including dental, optometrist, mental care, maternity, registered Traditional Chinese Medicine TCM and Chiropractic.
• Corporate membership discount and many more to explore.

Equal Opportunity Statement

Touch ‘n Go is an organization that strives to provide Equal Opportunity Employment, based on merit, qualifications, capabilities, and calibre. It is Touch ‘n Go’s policy to not discriminate based on age, race, religion, colour or other personal status, identity or characteristics. Fair Opportunity is Our Value and Practice. Please advise us of any accommodations you may need by e-mailing:

Note: Only shortlisted candidates will be contacted

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Consulting

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Key Result Areas (Regulatory)

• Adherence to AZ and industry codes of conduct, ethics, PhAMA code & Good Regulatory Practices.
• Maintenance of product licenses to a high standard throughout current year, with zero negative impact to business objectives & financial targets.
• Develop & implement regulatory strategy for responsible therapeutic area to achieve rapid & high-quality approvals & facilitate rapid launch.
• Provide guidance and functional support to regulatory team member.
• Monitor & interpret the local & global regulatory environment for significant changes & communicate implications of such changes to key stakeholders.
• Develop excellent relationships & partnerships with Health Authorities and regulatory KEEs.
• Proactive cross-functional teamwork contributing to optimum business strategies.
• Manage legal (including contracts) & Patent-related matters.
• Manage regulatory vendors and suppliers according to AZ requirements where applicable.
• Act as Company Pharmacist and Poison A License holder for the company.
• As Provisional Registered Pharmacist (PRP) Preceptor for the company (if require).

Typical Accountabilities

• Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to Regulatory Affairs.
• Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.
• Report potential issues of non-compliance

Education, Qualifications, Skills and Experience

Essential

• Pharmacy or Scientific Degree or equivalent professional qualification in related field
• Minimal 5 years of experience in regulatory affairs area.

• Post-graduate qualification

Key Relationships to reach solutions

Internal

• Country Leadership Team
• Country Cross Functional Team (Quality Assurance, Commercial, Medical, Supply Chain, HR, Finance, Market Access/Tender, Corporate Communications)
• Manufacturing Site, GRAPSQA, Global Supply Chain
• Quality Functional Leadership Teams

External

• Regulatory bodies
• Pharmaceutical companies
• Distributors
• Local Trade Associations
• HCPs & KEEs

Date Posted

27-Ogo-2025

Closing Date

26-Sep-2025

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Regulatory Affairs Manager

Biomed Global Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from Biomed Global

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Position: Regulatory Affair Manager

Industry: Healthcare/ Medical Device

Responsibilities

• Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
• Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
• Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
• Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
• Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
• Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
• Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
• Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
• Ensure compliance with advertisement and labeling regulations in each marketing territory.
• Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
• Plan and lead the implementation of internal RA audits on an annual basis.
• Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
• Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
• Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
• Support regulatory matters related to custom import requirements and documentation.
• Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.

Qualifications

• Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.

Required Skills

• Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
• Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
• Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers, effectively.
• In-depth knowledge and hands-on experience in medical device registration and regulatory compliance , particularly in Malaysia, Singapore, and Indonesia.
• Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
• Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
• Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
• Meticulous and detail-oriented, capable of working independently with minimal supervision.
• Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
• Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
• Pharmacist background with a valid license will be an added advantage.

Seniority level

• Seniority level Not Applicable

Employment type

• Employment type Full-time

Job function

• Job function Management, Legal, and Strategy/Planning
• Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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Getz Healthcare, Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia

Overview

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.

Responsibilities

• Ensuring compliance with local and international regulatory requirements for products and services.
• Communicating with business partners to gather documents required for product registration within the required time frame.
• 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.
• Preparing, submitting, and managing regulatory filings, including applications, renewals, and changes.
• Collaborating with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards.
• Monitoring and interpreting changes in regulations to advise the company on necessary adjustments.
• Communicating with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance.
• Maintaining accurate documentation and records to support audits and inspections.
• Providing guidance and training to teams on regulatory requirements and best practices.
• 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.

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

• Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders.
• Highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments.
• Well-organized and capable of managing multiple regulatory processes efficiently.
• Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions.
• Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment.
• Familiarity with relevant regulatory frameworks and digital tools for documentation management (e.g., AI, SharePoint).
• Handling electronic submissions and regulatory databases.

Job Details

• Seniority level: Entry level
• Employment type: Other
• Job function: Legal
• Industries: Medical Equipment Manufacturing

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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

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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.
**The Position**
**Job Purpose**
+ Opportunity for self-organized, high-achieving and team-oriented talent with medical/scientific and/or business background to make a difference to patients and gain professional experience in a leading multinational company in the healthcare/pharmaceutical/biotechnology industry.
+ Roche is a global healthcare company with a 125 year history and our ongoing success is based on our strong focus on science, innovation and delivering meaningful value for our customers and society.
+ 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.
**Responsibilities and Accountabilities**
As a Regulatory Affairs intern in Roche Pharma Malaysia, you may be assigned to a variety of tasks and/or projects relevant for the assigned team/function.
The objective of assignments is for the intern to practically apply academic or vocational studies/learning in a Roche setting, as well as learn more about the Roche organization, as future employment with Roche may be a possibility subject to job availability, candidate qualification and past performance.
Assignments will vary but are typically to support the activities of regular employees, such as supporting creation of work instructions, generating reports, ensuring data accuracy across different IT platforms and improving basic departmental operations such as filing or archiving systems.
For assignments in Regulatory Affairs, key responsibilities as intern may include but not limited to the following aspects (with appropriate guidance from experienced colleagues):
● Support planning, preparation and implementation of artworks
● Data entry and generate compliance reports as deemed necessary
● Review data accuracy across different systems
● Support functional operational work, which include but is not limited to filing and archiving activities
● Follow up on liaison matters with internal stakeholders
The length of the internship will vary according to business needs
**Competencies**
**Job Specific Competencies:**
+ Purpose-driven, passionate to make an impact to patients and society
+ Strong self-organization and high achiever
+ Growth mindset, able to learn and unlearn quickly, take risks and experiment, and contribute to the learning cycle by sharing knowledge with others inside and outside Roche
+ Strong communication and engagement skills
+ Display of integrity in everything
**Expertise**
+ Able to understand and use digital means and tools
+ Proficiency in English; fluency in Malay and/or Chinese language is a plus
**Education / Qualifications:**
+ Degree in Medical/Scientific and/or business background (e.g., Science/Medical/Pharmacy students, or Business Administration/Economics students with good understanding of medical-scientific concepts and terminology)
**Who we are**
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.**

**Job Description Summary**
**Job Description**
P3-14314
Required Skills
Optional Skills
.
**Primary Work Location**
MYS Kedah - Bard Kulim (Malaysia)
**Additional Locations**
**Work Shift**
MY3 Normal 8a-4.45p Group 26 (Malaysia)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Overview

Direct message the job poster from Novugen Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market. Our manufacturing facilities in Bandar Enstek, Negeri Sembilan, are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards. At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world. Together, we are shaping the future of healthcare and changing lives everywhere. About the role

The Executive, Regulatory Affairs

is responsible to support the company’s regulatory compliance by preparing, compiling, submitting, and maintaining regulatory documentation for product registration dossiers, variation applications, and renewals in compliance with local regulatory requirements (e.g., NPRA, HSA, FDA, EMA, etc.). Senior roles will provide more strategic input and independently manage product portfolios or projects. Key Responsibilities

Authoring and submission of (all modules – M1 to M5) of Original ANDAs, response to queries, and life cycle management of dossier such as annual reports, CBE, CBE-30 and PAS. Ensure no major queries during review cycle to secure the first review cycle approval and ensure the GDUFA goal dates are met Ensure GDUFA requirements such as Drug listing, Fee, Self-identification of facilities etc. Identify, review, and approve the required documents received towards dossier compilation including R&D documents viz. IIG clearance, PDR, QoS, analytical methods validation protocols and reports; Review plant documents such as raw material, packaging material and finished product specifications and test procedures, batch records, process validation documents, all types of stability protocols and reports, and analytical method transfer/verification protocols and reports etc., Writing Controlled correspondences (standard and complex) correspondences Thorough understanding on USP and EP requirements while reviewing the specification and keep updating the team with the current requirements. Review and compilation of relevant section of clinical, bio analytical reports, and bio-summary tables received towards the regulatory submissions Compilation and review of labelling documents PIL, medication guide and review of art works in accordance with PLR labelling requirements Review/Approve the change controls and deviations related to RA decision tree To liaise with various contract organizations, and other outside stake holders on current Agency’s regulatory requirements and align them with product goals. Ensuring regulatory compliances of DMFs in connection with marketing applications Compilation of SPL, ACTD, CTD and eCTD formats. Ensuring publishing activities and submission of dossiers via ESG with zero validation errors Regulatory Monitoring of an Approved Products About you

Bachelor’s degree in pharmacology or relevant. 3 years related experience in Pharma, FMCG, and Healthcare industries. Familiarity with ACTD/CTD/eCTD dossier formats and ASEAN/Common Technical Requirements (ACTR) as well as for overall global markers is an advantage Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance of Generic products in ASEAN and other regulatory markets. Strong coordination with cross-functional teams to ensure timely documentation for original submissions, RTQs, and supplements, while effectively communicating, negotiating, and fostering diplomatic, collaborative working relationships. Strong intrapreneurial skills and mindset from start up to established organization. Versatile, meticulous and resilient, ability to multitask and stay positive in high-pressure ambiguous environments and work towards delivering results Proficient in Microsoft Office Suite Proficient in using software/tools relevant to the pharmaceutical or healthcare industry etc Seniority level

Associate Employment type

Full-time Job function

Research Industries

Pharmaceutical Manufacturing

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Getz Healthcare, Taman Tun Dr Ismail, Federal Territory of Kuala Lumpur, Malaysia Overview

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. Responsibilities

Ensuring compliance with local and international regulatory requirements for products and services. Communicating with business partners to gather documents required for product registration within the required time frame. 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. Preparing, submitting, and managing regulatory filings, including applications, renewals, and changes. Collaborating with cross-functional teams and external agencies to ensure products meet legal, industry and quality management standards. Monitoring and interpreting changes in regulations to advise the company on necessary adjustments. Communicating with regulatory authorities and third-party agents to obtain approvals, resolve issues, and maintain compliance. Maintaining accurate documentation and records to support audits and inspections. Providing guidance and training to teams on regulatory requirements and best practices. 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. 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

Strong proficiency in both written and spoken English, with excellent communication skills for liaising with internal and external stakeholders. Highly detail-oriented with an analytical mindset, ensuring accuracy in regulatory documentation and compliance assessments. Well-organized and capable of managing multiple regulatory processes efficiently. Proactive in problem-solving, with the ability to assess risks and determine appropriate solutions. Adaptability to evolving regulatory requirements and the ability to work in a fast-paced environment. Familiarity with relevant regulatory frameworks and digital tools for documentation management (e.g., AI, SharePoint). Handling electronic submissions and regulatory databases. Job Details

Seniority level: Entry level Employment type: Other Job function: Legal Industries: Medical Equipment Manufacturing

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