Senior RAQA Specialist

A leading healthcare organisation in Petaling Jaya is seeking a Senior Regulatory Affairs and Quality Assurance Specialist to join their dedicated team. This role offers you the opportunity to make a meaningful impact by ensuring that life-saving products meet stringent regulatory and quality standards, supporting the licensing of drugs, biologics, and medical devices.

What you'll do:

As a Senior Regulatory Affairs and Quality Assurance Specialist based in Petaling Jaya, you will play a pivotal role in implementing local regulatory strategies for drugs, biologics, and medical devices. Your day-to-day responsibilities will involve developing project plans that ensure compliance with evolving regulations while supporting product licensing efforts. You will provide expert advice to project teams on regulatory matters, compile essential documentation for submissions, maintain existing authorisations, prepare SOPs tailored to local needs, and lead or represent Regulatory Affairs in various projects. Additionally, you will oversee quality assurance functions such as managing product complaints—including investigation and reporting—ensuring adherence to GDP standards through meticulous documentation control. Your ability to guide junior colleagues and manage supplier relationships will be crucial for maintaining high standards across all operations. Success in this role requires attention to detail, effective communication skills, strong organisational abilities for multitasking across multiple projects simultaneously, and a collaborative approach that fosters trust within the team.

• Develop and execute regulatory project plans under guidance, ensuring timely completion of all required activities for drugs, biologics, and medical devices.
• Identify key areas of regulatory risk and escalate concerns as needed while maintaining awareness of evolving local requirements.
• Participate actively as a team member by providing regulatory advice to project teams and responding promptly to questions from authorities within strict timelines.
• Compile, submit, maintain, and update regulatory documents according to local regulations for product authorisations.
• Support regulatory activities related to specific portfolios of products or projects including labelling review and AdProm material compliance.
• Prepare Standard Operating Procedures (SOPs) reflecting local requirements and represent Regulatory Affairs in small project teams when necessary.
• Guide junior team members by sharing knowledge and offering support during complex regulatory processes.
• Appoint as designated person/QMR for GDPMD responsibilities including product complaint management, non-conformance handling, recalls, FAs, and procedure compliance.
• Ensure completion of Product Complaint reporting within required timeframes; investigate returned samples for root cause analysis; follow up on potential Medical or Adverse Event complaints according to corporate requirements.
• Manage documentation control including record retention, compliance with Good Documentation Practices (GDP), SOPs, internal/external/supplier audits, supplier management with support from supplier quality function, data gathering for Quality Reviews/Complaints at required frequency.

What you bring:

To excel as a Senior Regulatory Affairs and Quality Assurance Specialist in Petaling Jaya’s healthcare sector, you should bring substantial experience gained from working with pharmaceuticals or medical devices locally. Your academic background ideally includes pharmacy or science disciplines complemented by hands-on exposure to regulatory affairs within healthcare environments. Familiarity with Malaysian registration procedures—covering new applications as well as renewals—is critical alongside knowledge of evolving legal frameworks governing drugs/medical devices. Your ability to manage complex projects concurrently while maintaining rigorous documentation standards will set you apart. Interpersonal skills are key: you must communicate clearly with authorities/stakeholders while negotiating solutions that uphold compliance. Technical proficiency ensures smooth operation across digital platforms used for record-keeping/research. If you hold a pharmacist license or have worked extensively with GDPMD standards your application will be particularly valued. Above all else your dependability—demonstrated through consistent attention to detail—and willingness to share knowledge/support others will help foster an inclusive workplace where everyone thrives.

• Degree in pharmacy, science or related discipline is highly desirable for this position.
• At least five years of relevant experience in pharmaceutical, biologics or medical device sectors within Malaysia is essential.
• Regulatory affairs experience within a healthcare environment is mandatory; quality assurance experience is strongly preferred.
• Pharmacist License is advantageous but not required; familiarity with new registration processes, license extensions, variations and renewals in Malaysia is important.
• Comprehensive knowledge of applicable regulatory laws/acts with proven ability to adapt to changing scope/evolving regulations is expected.
• Experience with both drug and medical device registration processes provides added value.
• Good understanding of GDPMD standards (GDP for Medical Devices) is necessary for success in this role.
• Project management skills enabling you to handle multiple projects/deadlines efficiently are vital.
• Excellent interpersonal communication skills combined with negotiation abilities are required for effective stakeholder engagement.
• Technical system proficiency (word processing/spreadsheets/databases/online research) supports accurate documentation control.

What sets this company apart:

This organisation stands out as a leader in redefining healthcare delivery by prioritising compassion, trustworthiness, collaboration among colleagues, and genuine commitment to saving lives. Employees are united by a shared mission that goes beyond business goals—every action taken contributes directly toward improving patient outcomes across Malaysia. The company’s culture encourages open communication where every individual feels empowered to make meaningful contributions regardless of their background or experience level. Flexible working arrangements allow you to balance professional ambitions with personal wellbeing while generous pension contributions provide long-term security. Training opportunities abound so you can continually expand your skillset alongside knowledgeable peers who value teamwork above all else. Here you’ll find more than just employment—you’ll discover purpose-driven work supported by leaders who nurture growth through supportive leadership practices. The organisation’s dedication to inclusivity means under-represented voices are heard; everyone shares responsibility for delivering exceptional results together.

What's next:

If you are ready to make a real difference in healthcare regulation and quality assurance while enjoying flexible benefits in an inclusive environment—apply now!

Apply today by clicking on the link provided.

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C