192 Pharmaceutical jobs in Malaysia

Regulatory Affairs Manager, MSI

Kuala Lumpur, Kuala Lumpur Boehringer Ingelheim

Posted 3 days ago

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Job Description

The Position **

This role is responsible for leading timely and successful product registrations in alignment with both corporate objectives and local regulatory requirements. It plays a critical part in ensuring full compliance with applicable laws, guidelines, and industry standards governing the importation, licensing, and control of therapeutic products.

You are require to collaborate with internal stakeholders and health authorities to navigate regulatory pathways efficiently and effectively. In addition to managing submissions and approvals, the role contributes strategic input to regulatory planning, supports cross-functional initiatives, and helps shape local regulatory strategies that enable market access and long-term business sustainability.

Duties and Responsibilities: **

  1. Regulatory Planning and Submission Strategy
  • Manage all regulatory tasks and projects, including obtaining and maintaining product and operational licenses for the assigned portfolio on behalf of BI, as required by local regulations.

  • Prepare and submit regulatory applications for the assigned portfolio, ensuring timely approvals.

  • Develop local registration plans in alignment with local business objectives and global regulatory strategy.

  • Monitor the progress of submissions and coordinate timely responses to all questions from health authorities for the assigned portfolio.

  • Ensure compliance with corporate policies, regulations, and procedures, particularly the implementation of the current Company Core Data Sheet (CCDS), Change Review Committee (CRC), and local change control procedures.

  • Manage regulatory submissions to support clinical trial activities in the OPU, if applicable.

  1. Regulatory Intelligence and Interaction
  • Keep the local Regulatory Affairs (RA) team and ROPU informed of new regulations or updates.

  • Ensure timely regulatory impact assessments.

  • Maintain close relationships with relevant health authorities and other organizations/key stakeholders to facilitate and develop effective collaboration on regulatory interactions.

  • Communicate with health authorities and local industry groups on regulatory issues.

  1. Cross-Functional Collaboration and Support
  • Provide regulatory consultation and collaborate with local business stakeholders

  • Ensure that product promotion in the market complies with local and global regulatory frameworks to sustain and expand the business

  • Participate in the promotional material approval process to ensure regulatory compliance

  • Provide feedback to global teams and participate in global initiatives when required

  1. Quality and Compliance
  • Ensure timely submission of CCDS updates, CRC changes, renewals, PSURs, and other local variations in compliance with internal KPIs

  • Maintain regulatory databases to reflect current registration status and regulatory requirements

  • Ensure that timelines for regulatory review in the e-MLR process are met and that promotional materials comply with local regulations

  • Contribute to audits, CAPA processes as appropriate, and support local inspection readiness

  • Archive local regulatory submission documents in accordance with internal standards

  1. Deputy Role and Training Support to Local RA Team
  • Fulfill the responsibilities of the Head of Regulatory Affairs in their absence

  • Act as a mentor by providing guidance and actively training other team members in regulatory tasks, where appropriate

Requirements: **

  • Bachelor’s degree; Degree in Pharmacy preferred

  • Over 7 years of experience in the pharmaceutical, medical device, or healthcare industry

  • Background in regulatory affairs or a related discipline is an advantage

  • Solid understanding of drug development and national regulatory procedures

  • Technical expertise in at least one therapeutic or regulatory area (e.g., CMC, clinical)

  • Proven ability to interact with health authorities and navigate local regulatory requirements

  • Strong communication skills for both internal and external stakeholders

  • Proficient in English (written and verbal)

  • Comfortable working with databases; strong computer literacy

  • Effective in cross-functional, matrix environments

  • Proactive, assertive, and collaborative team player

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

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Senior Regulatory Affairs Specialist, APAC

ZOLL Medical Corporation

Posted 4 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 Science Liaison, Oncology - Solid Tumor

Petaling Jaya, Selangor AbbVie

Posted 5 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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TA Head, Oncology, APMA

Negeri Sembilan, Negeri Sembilan Novartis

Posted 5 days ago

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Job Description

Summary

To lead, manage and develop the overall performance of the therapeutic area's current and future product portfolio, with oversight of the execution of pre-launch and launch plans across all line functions (Access, Commercial & Medical). Will collaborate with country/cluster teams to help them drive brand performance and develop operational strategies for the organization, and guide and support the implementation of innovative commercial models. Will also be responsible for overseeing implementation of market access and policy strategies to ensure the successful launch and growth of the TA pipeline portfolio across the region, in alignment with global strategies. The purpose of this role will be to provide oversight and support to the local team to ensure the successful implementation of go-to-market strategies for the TA across the region.

About the Role

Major Accountabilities

  • Lead the development and implementation of a cross-functional, regional business plan for the TA (including country identification, sequencing, market entry, revenue targets, resource allocation, etc.), and business case review and approval (e.g., geographic expansion) in partnership with relevant global functions and regional leadership.
  • Lead the TA portfolio launches for the region (strategy and oversee implementation of commercial, medical & access plans).
  • Support price negotiation for pipeline products with above country level stakeholders, ministries of health, etc while defending the reputation of Novartis.
  • Build and foster relationships with the top-tier key opinion leaders/experts, academic institutions and medical societies, patient advocacy groups and policy-making organizations, in close collaboration with regional leadership and other global functions.
  • Partner with key internal and external stakeholders to develop appropriate plans aimed at raising awareness of unmet needs.
  • Ensure that there is a clear understanding of the patient management paradigm, including a deep and unified understanding of the patient journey across the region.
  • Continue to gain deep customer insights and translate them into key actions and decisions.
  • Ensure launch plans have a clear lens for Access success in various channels including private, public and out of pocket segments.
  • Accountable for execution of overall TA portfolio spend within budget, and oversee and monitor the overall commercial and medical budgets, strategic plans, and associated metrics for the TA.
  • Optimize sales force performance and return on investment across the region. Enhance sales force capabilities and continue to develop innovative commercial strategies to ensure success in an evolving healthcare environment.
  • Drive TA presence at selected key regional congresses, symposia, industry meetings and education initiatives for healthcare professionals in close partnership with global cross-functional stakeholders and regional leadership.
  • Cross functional representation of region in global forums as the single point of contact.
  • Ensure that all sales & marketing activities are in accordance with the guidelines of the Company’s Code of Conduct.
  • Develop and manage key talents across region in the TA, build community of leaders, and foster innovation and performance mindset across region within the TA.
  • Drive the spirit of “ONE Team” with “We over Me” mindset across all functions by supporting a team approach to focus on our patients, payers and customers as our top priorities.

Key Performance Indicators:

  • Region brand performance, according to defined targets.
  • Launch of pipeline products according to budget and business plans. Prepare launches for upcoming products in the therapeutic area pipeline.
  • Quality and timely implementation of business and medical plans in alignment with Global brand strategies.
  • Implementation of innovative commercial model.
  • Operational excellence.

Experience:

  • 10+ years of relevant experience working with high- performing regional and local marketing, medical and or access teams in healthcare/life sciences industry.
  • Track record of highly successful delivery and positive performance results.
  • Proven ability to drive successful launches.
  • Reliable self-starter, proactive, initiator, change agent.
  • Demonstrable leadership skills and experience engaging with and introducing innovation into HCS.
  • In depth knowledge of customer/marketplace, key dynamics and current knowledge of key competitors and their likely strategies within TA.
  • He/she must be comfortable working as the first employee in this new organization; in other words, a hands-on, roll-up sleeves approach will be essential.
  • Travel as required.
  • Able to analyze financial data as well as industry data related to sales, market share, price/volume, call activity, market research, etc. Able to credibly articulate data related to market trends, performance, and strategies to achieve goals to various internal and external audiences.
  • While entrepreneurial, ability to maintain the highest degree of integrity, represent the company’s high ethics, moral behavior, and professionalism.
  • The highest ethics and moral standards; unquestioned integrity needed for the complexity of this role.

Education:

  • University degree (science, business, policy).
  • MBA or Doctoral degree (MD/Pharm. D/PhD) preferred.

Language:

  • English fluent spoken & written. The ability to speak multiple languages will be advantageous.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally:

Division International Business Unit Innovative Medicines

Location Singapore

Site Mapletree Business City (MBC)

Company / Legal Entity SG90 (FCRS = SG015) Novartis Asia Pacific Pharmaceuticals Pte. Ltd

Functional Area Commercial & General Management

Job Type Full time

Employment Type Regular

Shift Work No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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Medical Affairs Manager

Kuala Lumpur, Kuala Lumpur Businesslist

Posted 6 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 6 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 .)

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Medical Affairs Manager

Petaling Jaya, Selangor AstraZeneca

Posted 17 days ago

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Job Description

AstraZeneca is one of the world's leading pharmaceutical companies, with a broad range of medicines designed to fight disease in meaningful areas of healthcare: cardiovascular, diabetes, respiratory and cancer.

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We believe in the potential of our people and you’ll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to achieve our shared goals no matter where you start with us. When we see an opportunity for change we seize it and make it happen, because an opportunity no matter how small can be the start of something big. Delivering life changing medicines is about being entrepreneurial finding those moments and recognising their potential.

Key Responsibilities

  • An internal and externally facing medical role that provides medical and clinical expertise in priority therapeutic/disease areas and builds AZ scientific leadership.

  • Participates and contributes with medical and clinical expertise in design of LCM and Brand Strategy.

  • Takes leadership in implementation of Medical Plan/ activities in alignment with Brand strategy.

  • Engages Key External Experts (KEEs) in ESRs, scientific exchange meetings and advisory board meetings.

  • May take responsibility as Nominated Signatory medical reviewer for activities and promotional materials.

  • Assumes direct line management responsibilities for Medical Scientific Liaisons (MSLs) / Medical Advisors (MAs) within Therapeutic Area

Requirements

  • Your education background is in medical ( MBBS/MD) , preferably with a MSc/PHD in a scientific discipline

  • 3-4 years Medical Affairs Experience

  • You have medical or scientific knowledge in the responsible disease area and interest in the pharmaceutical and healthcare industry

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ ies where the role is advertised.

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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Regulatory Affairs Manager

Petaling Jaya, Selangor AstraZeneca

Posted 19 days ago

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Job Description

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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Regulatory Affairs Manager

Kuala Lumpur, Kuala Lumpur Biomed Global

Posted 22 days ago

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Job Description

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

Regulatory Affairs Manager

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

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Talent Management Specialist |Just your friendly neighborhood Recruiter | Career Match-Maker| I don't usually stalk Profiles, but when I do I…

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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CRA II

Kuala Lumpur, Kuala Lumpur Pharmaceutical Research Associates, Inc

Posted 1 day ago

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Job Description

Overview

As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be working alongside a world-leading pharmaceutical company. This 19- year partnership is focused on leveraging cutting-edge science to make a positive impact in the therapeutic areas of cancer, cardio-metabolic, vaccines, and oncology, which makes up 70% of their portfolio. If you’re looking to make difference, this could be the career destination for you.

Responsibilities

What you will be doing:

  • Site monitoring from site selection to study close out
  • Monitor the progress of assigned clinical trials and escalate any protocal deviation, SAE, risk to timely completion of study milestones
  • Submit monitoring visit report to Clinical Trial Manager on time
  • Cross functional collaboration with site staff, PI, CTM, CTA, contracts and SSU team
  • Monitoring in global oncology studies, including on site and remote monitoring visit
  • Approx 50% travel, hybrid office based
Qualifications

You are:

  • Tertiary degree qualified in Life Sciences
  • 2+ years independent site monitoring experience
  • Ideally previous exposure to Oncology trials
  • Excellent communication and presentation skills
  • Experience working within CRO/Pharma industry is essential

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

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