231 Pharmaceutical jobs in Malaysia

Medical Science Liaison, Oncology - Solid Tumor

Petaling Jaya, Selangor Hispanic Alliance for Career Enhancement

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Job Description

Overview

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

The MSL Oncology – Solid Tumor will play a crucial role in AbbVie's preparedness for the launch of new oncology products that require companion molecular diagnostics. This individual will be responsible for helping assess AbbVie's readiness for new precision medicine assets, addressing evidence and educational gaps and collaborating with external scientific stakeholders to develop partnerships that support and expedite opportunities for patients to access AbbVie's precision medicines.

Responsibilities
  • Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
  • Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
  • Support internal teams such as sales, marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
  • Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D (GPRD) SOPs.
  • Act as the point of contact with thought leaders to facilitate Investigator Initiated Study (IIS) ideas and requests for support to the local and global medical teams as appropriate.
  • Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.
  • Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested, with the focus on Tier 1 and 2 thought leaders.
  • Participate in the selection process to identify appropriately qualified thought leaders the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
  • Facilitate medical and scientific field intelligence – for example, competitor research and medical strategies, educational activities – and communicate, where appropriate, within the Company.
  • Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives. Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
  • Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
  • Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.

Location: This function is typically field based role. Typically, up to 20% of an individual's time may be spent working in the affiliate medical team head office – the remainder of time being spent as field based. This is subject to local needs, and the discretion of the ASEAN Medical Director.

Qualifications
  • Medical, Pharmacy or other bachelor's degree in scientific discipline or higher (PhD)
  • A background in diagnostics, the diagnostic industry, medical affairs or a related field, along with experience in working closely with the pharmaceutical industry.
  • Strong understanding of precision medicine and companion diagnostics, including the regulatory and payer landscape in Singapore.
  • Excellent communication and proven relationship-building skills in effectively establishing new links with external stakeholders.
  • Possess strong organizational skills, the ability to work collaboratively with cross-functional teams.
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.
Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit the information provided by AbbVie about equal employment opportunity.

US & Puerto Rico applicants seeking a reasonable accommodation, see the information provided by AbbVie about reasonable accommodations.

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Medical Science Liaison (Oncology)

Kuala Lumpur, Kuala Lumpur Randstad Malaysia

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Job Description

Our client is a global biotech company specialising in early disease detection. They develop tests to screen for cancers and other diseases, with the mission of improving and saving lives through preventive healthcare.

Reporting to: Medical Affairs Manager

Location: Kuala Lumpur

Work type: Hybrid

Rewarding base salary

The Role:
  • Lead Medical Strategy: Execute local medical plans and pre-launch activities, ensuring alignment across all internal teams (Commercial, Regulatory, etc.).
  • Expert Engagement: Build and maintain peer-to-peer relationships with Key Opinion Leaders (KOLs) for scientific exchange and to support initiatives.
  • Scientific Resource: Act as the therapeutic expert, providing balanced medical information to healthcare professionals and gathering critical field insights to inform company strategy.
  • Ensure Compliance & Access: Uphold all regulatory and ethical standards while actively supporting patient access programs.
The Experience:
  • Bachelor degree in any Science disciplines.
  • Proven analytical skills and ability to communicate scientific information.
  • Skilled in operations management and collaborating across different functional.

We are an equal opportunities employer and welcome applications from all qualified candidates.

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Senior Regulatory Affairs Specialist, APAC

Selangor, Selangor ZOLL Medical Corporation

Posted 2 days ago

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Job Description

Acute Care Technology

Job Summary

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

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

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

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

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

The Regulatory Affairs Specialist

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

Essential Functions
  • Maintain working knowledge of APAC medical regulations, as well as FDA and European Medical Device Regulations (MDR); familiarity with ISO 13485 is a plus
  • Participate in cross-functional product core teams to ensure compliance with internal policies and external regulatory requirements
  • Develop, document, and implement regulatory strategy plans aligned with product development objectives
  • Prepare technical dossiers and regulatory submissions for target markets
  • Draft and submit responses to regulatory agencies with clear, concise, and well-structured communication
  • Assess the regulatory impact of product and process changes in accordance with APAC regulations and standards
  • Implement and maintain standardized submission templates and documentation
  • Maintain regulatory files and product licenses in a well-organized and up-to-date manner
  • Stay current with global medical device regulations, guidance, and standards; analyze updates and communicate key changes to relevant stakeholders
  • Participate in continuous improvement activities within the department, and propose process enhancements to improve submission efficiency and accuracy
  • Support device recall activities as needed
  • Participate in internal audit activities as an auditor
Required Education And Experience
  • Bachelor’s degree in a relevant field
  • 3 to 5 years of regulatory affairs experience, preferably in the healthcare or medical device industry
Key Skills And Attributes
  • Strong organizational and time-management skills
  • Ability to work independently and collaboratively in a team environment
  • Detail-oriented, responsible, and proactive
  • Able to perform under pressure and meet deadlines
  • Strong written and verbal communication skills

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

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Medical Science Liaison, Oncology - Solid Tumor

Petaling Jaya, Selangor AbbVie

Posted 6 days ago

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Job Description

Medical Science Liaison, Oncology - Solid Tumor

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Overview

The MSL Oncology – Solid Tumor will play a crucial role in AbbVie’s preparedness for the launch of new oncology products that require companion molecular diagnostics. This individual will be responsible for helping assess AbbVie’s readiness for new precision medicine assets, addressing evidence and educational gaps and collaborating with external scientific stakeholders to develop partnerships that support and expedite opportunities for patients to access AbbVie’s precision medicines.

Responsibilities
  • Provide scientific and technical leadership to ensure professional and credible relationships with thought leaders and external experts of strategic importance to AbbVie.
  • Ensure a strong medical and scientific presence for AbbVie in key academic centers by facilitation of research and educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to AbbVie.
  • Support internal teams such as sales, marketing and members of the Affiliate Brand Team to develop their scientific and technical expertise through the delivery of scientific update presentations. Work collaboratively and cross-functionally with other in-field members while retaining functional independence.
  • Assist in the initiation; oversight and follow up of assigned clinical studies and medical projects initiated within the therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV). All such activities must comply with applicable local laws, guidelines, codes of practice, SOPs, and AbbVie R&D (GPRD) SOPs.
  • Act as the point of contact with thought leaders to facilitate Investigator Initiated Study (IIS) ideas and requests for support to the local and global medical teams as appropriate.
  • Serve as a point of contact within the Medical Affairs team for thought leaders and external experts within an assigned geographic area to satisfy their needs for scientific knowledge in a therapeutic area and, when requested, relevant AbbVie medicines, to support their safe, effective and appropriate use.
  • Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested, with a focus on Tier 1 and 2 thought leaders.
  • Participate in the selection process to identify appropriately qualified thought leaders the Company would wish to engage in collaborative efforts – such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts.
  • Facilitate medical and scientific field intelligence – for example, competitor research and medical strategies, educational activities – and communicate, where appropriate, within the Company.
  • Attend relevant scientific meetings and Conferences. Collaborate with internal stakeholders to develop summaries of key data and other scientifically relevant information to inform AbbVie strategic priorities and initiatives. Upon request, assist physicians with requests for access to AbbVie medicines on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
  • Provide key thought leaders / external experts and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
  • Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.

Location: This function is typically field based role. Typically, up to 20% of an individual’s time may be spent working in the affiliate medical team head office – the remainder of time being spent as field based. This is subject to local needs, and the discretion of the ASEAN Medical Director.

Qualifications
  • Medical, Pharmacy or other bachelor’s degree in scientific discipline or higher (PhD)
  • A background in diagnostics, the diagnostic industry, medical affairs or a related field, along with experience in working closely with the pharmaceutical industry.
  • Strong understanding of precision medicine and companion diagnostics, including the regulatory and payer landscape in Singapore.
  • Excellent communication and proven relationship-building skills in effectively establishing new links with external stakeholders.
  • Possess strong organizational skills, the ability to work collaboratively with cross-functional teams.
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Seniority level

  • Entry level

Employment type

  • Full-time

Job function

  • Research, Analyst, and Information Technology

Industries

  • Pharmaceutical Manufacturing and Biotechnology Research

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Medical Science Liaison - Southeast Asia

Shah Alam, Selangor Clinigen

Posted 11 days ago

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Job Description

Overview

The Medical Science Liaison (MSL) for Southeast Asia at Clinigen plays a pivotal role in bridging the gap between scientific research and clinical practice. This field-based position necessitates the establishment and maintenance of strategic relationships with key opinion leaders (KOLs), healthcare professionals, and academic institutions to support the introduction and uptake of medical products across the region.

Key Responsibilities
  • Develop and sustain professional relationships with KOLs and healthcare providers in relevant therapeutic areas.
  • Gather and report insights from the medical community to inform strategy and product development.
  • Collaborate with internal teams to provide expertise and feedback on medical programs and initiatives.
  • Deliver scientific presentations and educational programs to healthcare professionals.
  • Maintain compliance with regulatory and ethical standards in all activities.
Essential Duties
  • Relationship Management
    • Identify and engage with key medical experts and stakeholders to establish collaborative relationships.
    • Facilitate scientific discussions and provide medical information relevant to product usage and patient care.
    • Support the design and implementation of investigator-initiated studies, advisory boards, and medical education initiatives.
  • Insights and Intelligence
    • Collect insights on current treatment landscapes and patient experiences to drive data-driven decision-making.
    • Provide feedback and guidance to internal teams regarding competitor products and marketplace trends.
  • Medical Education and Training
    • Deliver high-quality, scientifically accurate presentations and educational materials to healthcare providers.
    • Conduct training sessions for internal staff to enhance their understanding of therapeutic areas and product information.
  • Compliance and Administration
    • Ensure adherence to all applicable legal and regulatory guidelines in all MSL activities.
    • Maintain accurate documentation of interactions and communications with healthcare professionals.
    • Prepare reports and updates for management and stakeholders as required.
Qualifications
  • Advanced degree in a relevant scientific or medical field (Ph.D., Pharm.D., M.D.).
  • Prior experience in medical affairs or as a medical science liaison is highly desirable.
  • Strong familiarity with the therapeutic areas relevant to the role, especially in oncology, infectious diseases, or rare diseases.
  • In-depth understanding of compliance regulations and industry standards.
  • Exceptional communication and interpersonal skills, with the capacity to engage and influence diverse stakeholders.
  • Proficiency in English; proficiency in local languages is a significant advantage.
  • Willingness to travel extensively within Southeast Asia.
Benefits
  • A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication.
  • A performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your role.
  • Generous annual leave of 20 days, allowing you the opportunity to take time off for rest, relaxation, and personal pursuits, promoting a healthy work-life balance.
  • Ongoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization.

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Medical Science Liaison

Kuala Lumpur, Kuala Lumpur Mirxes

Posted 20 days ago

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Job Description

MiRXES is a Singapore-headquartered molecular diagnostic company with R&D, manufacturing, and clinical lab operations in Singapore, USA, Japan, and China. We specialize in microRNA technologies and the development, manufacturing, and provision of diagnostic test kits and clinical services. Our mission is to enable early disease detection and provide insights for better patient care by harnessing the power of microRNA to augment traditional testing. Our vision is to be the world’s leading developer and provider of accurate, actionable, and affordable microRNA-powered diagnostic tests.

Job Summary

The Scientific and Medical Affairs Team communicates the value of Mirxes’ technology, products, and services to external medical and scientific experts, by fostering relationships with key opinion leaders (KOLs), communicating scientific data, training internal stakeholders, and presenting educational information to external stakeholders.

We are seeking a Medical Science Liaisons (MSL) for the Early Disease Detection (EDD) business unit, who will be primarily responsible for KOL engagements, conducting continuous medical education (CME) events to external stakeholders, developing advocates and speakers for our products, answering product-related queries from clients, and leading data generation with scientific/medical collaborators. This role will drive efforts to enhance understanding of the scientific and medical value of Mirxes’ products and services among medical professionals.

Roles and Responsibilities

  • Develop and effectively execute KOL and external stakeholder engagement plans to gather data, develop, and share medical/scientific insights that contribute to Mirxes' key medical/scientific messages, plans and future R&D.
  • Establish and expand clinical network in the disease areas covered by Mirxes' products and pipeline.
  • Be the subject matter expert and resource centre by keeping abreast of the latest trends and developments in the field of EDD, and providing timely updates to external/internal stakeholders.
  • Conduct effective CMEs, disease area training and clinical case sharing for external and internal stakeholders.
  • Review clinical case reports with internal laboratory team and external laboratory partners to ensure accuracy of report findings and recommended follow-up actions.
  • Communicate and explain clinical report findings to ordering doctors as part of the post-report out services. Address any queries and troubleshoot any issues arise, so as to ensure customer satisfaction and retention.
  • Timely update and maintain a database of clinical cases.
  • Maintain a database of KOL engagement logs and ensure continuous and timely follow-ups on the deliverables.
  • Work collaboratively and compliantly with the commercial team to ensure full Medical Affairs support for new product and business launches in the territory country.
  • Support commercial team to develop, edit, and review clinical/scientific collaterals to ensure clinical/scientific accuracy, relevance to target audiences, and alignment to company's business and strategic objectives.
  • Collaborate with KOLs and clients to support global or local clinical/scientific studies to generate evidence that enhances the value of Mirxes’ products and services in the real-world setting.

Desired Skills and Competencies

  • Medical degree, PhD or equivalent, with 1-2 years of experience in early cancer screening (fresh PhD graduates may apply).
  • Well versed in the fields of early cancer detection and cancer screening.
  • Strong communication and presentation skills.
  • Strong interpersonal skills, especially the capability to engage in professional relationship building and networking with external stakeholders.
  • A highly motivated individual who can assimilate large amounts of scientific content which are then communicated in a clear and concise fashion to external or internal stakeholders.
  • An independent contributor who is also a strong team player.
  • An individual who knows how to collaborate, communicate with and engage various stakeholders across different functions in the company.
  • Proficient and fluent in English and Malay.

This position is based in KL, Malaysia.

We appreciate your interest in the above-mentioned position; however, only shortlisted candidates will be contacted.

Location : Kuala Lumpur, Malaysia

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Senior Regulatory Affairs Specialist, APAC

ZOLL Medical Corporation

Posted 25 days ago

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Job Description

Senior Regulatory Affairs Specialist, APAC

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

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

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

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

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

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

Essential Functions:

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

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

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

  • Prepare technical dossiers and regulatory submissions for target markets

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

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

  • Implement and maintain standardized submission templates and documentation

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

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

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

  • Support device recall activities as needed

  • Participate in internal audit activities as an auditor

Required Education and Experience:

  • Bachelor’s degree in a relevant field

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

Key Skills and Attributes:

  • Strong organizational and time-management skills

  • Ability to work independently and collaboratively in a team environment

  • Detail-oriented, responsible, and proactive

  • Able to perform under pressure and meet deadlines

  • Strong written and verbal communication skills


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

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Medical Affairs Manager

Kuala Lumpur, Kuala Lumpur Businesslist

Posted 27 days ago

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Job Description

  • Develop and execute medical strategies aligned with the company's objectives in the Pharmaceutical sector.
  • Provide scientific and medical expertise to support internal teams and external stakeholders.
  • Manage medical information requests and ensure compliance with regulatory standards.
  • Collaborate with cross-functional teams to support product launches, lifecycle management, patient access and other medical related programmes.
  • Establish and maintain strong relationships with key opinion leaders and healthcare professionals.
  • Lead the development of scientific materials and medical education programs.
  • Monitor and analyze market trends to identify opportunities for medical initiatives.
  • Ensure all medical activities adhere to ethical and compliance standards.
The Successful Applicant

A successful Medical Affairs Manager (Sole Contributor) should have:

  • A degree in medicine, pharmacy, or a related field in the life sciences industry.
  • At least 5 years of experience and proven expertise in medical affairs or a related scientific role.
  • Strong knowledge of regulatory guidelines and medical compliance practices.
  • Excellent communication and relationship-building skills with healthcare professionals.
  • A proactive approach to problem-solving and ability to work independently.
  • A passion for advancing healthcare through scientific innovation.
What's on Offer
  • Good remuneration package including fixed allowance and attractive performance bonus.
  • Opportunity to work with a leading organization in the pharmaceutical industry.
  • Collaborative and innovative work environment based in Kuala Lumpur.



We encourage professionals passionate about medical affairs and the life sciences industry to apply and take the next step in their career journey.

ContactChristine ChooQuote job refJN- Phone number #J-18808-Ljbffr
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Regulatory Affairs Manager

Kuala Lumpur, Kuala Lumpur Brunel

Posted 27 days ago

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Job Description

Brunel Federal Territory of Kuala Lumpur, Malaysia

Direct message the job poster from Brunel

Overview

APAC Life Sciences Expert (Pharma/Devices/Biotech)

Lead and manage all regulatory activities for the company’s portfolio across SEA. This role ensures compliance with local and regional regulations, facilitates market access, and provides strategic regulatory guidance to support business objectives.

Responsibilities
  • Develop and implement regulatory strategies to achieve timely approvals and market access across SEA countries.
  • Ensure products comply with local, regional, and international regulations and monitor regulatory changes to provide proactive guidance to the business.
  • Prepare, compile, and submit regulatory dossiers for product registration, renewals, and variations in SEA markets, coordinating with local distributors or partners as needed.
  • Liaise with regulatory authorities to facilitate approvals and address any questions or deficiencies.
  • Ensure compliance with post-market requirements, including vigilance, reporting, labeling, and quality system documentation, and support regulatory audits, inspections, and reporting requirements. Advise on regulatory implications of product changes, complaints, or recall.
  • Collaborate closely with R&D, QA/RA, Clinical, Marketing, and Supply Chain teams to ensure regulatory requirements are considered throughout the product lifecycle and provide regulatory input for new product development, clinical studies, and marketing initiatives.
  • Mentor and develop local regulatory staff or liaison teams and provide regulatory training to internal stakeholders.
Application

What you should do now

Apply to this job ad or send your CV across to me at for a confidential discussion.

(Brunel International South East Asia Pte Ltd, Registration Number: R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R .)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

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Process Engineer-C&Q (Pharmaceutical Manufacturing Operations)

Kuala Lumpur, Kuala Lumpur Unison Group

Posted today

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Job Description

Overview

Process Engineer-C&Q (Pharmaceutical Manufacturing Operations) – Unison Group, Kuala Lumpur, Malaysia

Location: Kuala Lumpur, Federal Territory of Kuala Lumpur, Malaysia

Responsibilities
  • Support C&Q execution for process equipment, utilities, and manufacturing systems
  • Review and execute qualification protocols (IQ, OQ, PQ) and support FAT/SAT activities
  • Provide process and operational input during commissioning and troubleshooting
  • Support DeltaV-related activities (recipes, phases, batch execution understanding)
  • Develop/review C&Q documentation (URS, risk assessments, protocols, reports)
  • Ensure adherence to GMP, regulatory, and data integrity requirements
  • Collaborate with operations, QA, and automation teams to meet project deliverables
Qualifications
  • Bachelor's degree in chemical / Biochemical / Process / Mechanical Engineering or related field
  • 4-6 years' experience in pharmaceutical/biotech manufacturing or operations, with exposure to C&Q
  • Strong process knowledge of pharmaceutical manufacturing
  • Working knowledge of DeltaV - recipes, batch execution, troubleshooting
  • Hands-on experience with C&Q documentation and execution (IQ, OQ, PQ)
  • Good knowledge of cGMP, FDA/EMA guidelines, and industry practices
Employment details
  • Seniority level: Associate
  • Employment type: Full-time
  • Base pay range: SGD60,000.00/yr - SGD72,000.00/yr

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  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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