Senior RAQA Specialist

Manpower Staffing Services (Malaysia) Sdn. Bhd.; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

Manpower Staffing Services (Malaysia) Sdn. Bhd. is seeking a Regulatory Affairs professional with at least 5 years’ experience in pharmaceuticals, biologics and medical devices in Malaysia. The role involves planning regulatory projects, identifying risks, and delivering compliant submissions.

You will respond to authorities within strict timelines, maintain authorizations, and guide junior staff while ensuring GDP and SOP compliance across projects.

Qualifications

• Degree in pharmacy, science or related discipline is an advantage.
• At least 5 years of relevant experience in pharmaceutical, biologics and medical devices in Malaysia.
• Regulatory and quality experience within a healthcare environment; Pharmacist license is an advantage.
• Knowledge of registration, license extensions, variations and renewals in Malaysia; drugs and medical devices registrations experience.
• Familiar with regulatory laws and evolving regulations in Malaysia.

Responsibilities

• Regulatory project planning and execution for pharma and medical devices.
• Identify regulatory risks and elevate them with project teams.
• Respond to regulatory authorities within timelines.
• Compile and submit regulatory documents per local requirements.
• Maintain existing regulatory authorizations; support related activities.
• Prepare/ review labeling and AdProm materials for compliance.
• Oversee SOPs reflecting local regulatory requirements.
• Lead regulatory affairs in small project teams; guide junior staff.
• Perform QA duties including complaint handling and product recalls where applicable.

Skills

Regulatory affairs expertise

Pharma/biologics knowledge

Medical devices experience

Regulatory risk identification

Regulatory documentation

Quality and GDP awareness

Education

Degree in pharmacy/science

Pharmacist license (advantage)

Tools

GDP & SOP understanding

Job description

• Strong experience in drugs and biologics
• Relevant experience in medical devices in Malaysia
• With direction, develop and execute regulatory project plans
• Identify and elevate key areas of regulatory risk
• Maintain awareness of regulatory requirements; identify relevant requirements
• Participate as an active team member and provide regulatory advice to project teams as required
• Respond to questions from regulatory authorities within strict timelines
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations
• Prepare SOPs to reflect specific local requirements.
• Represent or lead Regulatory Affairs in small project teams
• Provide guidance to junior team members when needed
• Perform other duties as assigned

For QA responsibilities

• Responsible for product complaint related matter/non-conformances/product recalls/FAs and ensure procedure compliance.
• Responsible for the completion of Product Complaint reporting to ensure notification to Complaint Coordinator within required timeframe and investigation of returned samples to determine root cause.
• Immediate follow-up of potential Medical or Adverse Event product complaints according to corporate requirements.
• Report, follow-up and trend product complaints.
• Responsible for FA related actions viz. customer notification letters, regulatory reporting and product recall activities.
• Reply to customer complaint, queries related to quality, presentation to customer on quality.
• Responsible for release of Finished Goods with temperature controlled and after routine redressing.
• Responsible for redressing instruction.
• Documentation control and maintenance of records (record retention) and ensure compliance with Regulatory Requirements, Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
• Oversee documentation to ensure completion of records and GDP Compliance
• Prepares SOP, Document Change Request (DCRs) and Periodic Review.
• Ensure compliance with SOPs, quality assurance, internal and local regulations and GDPMDS (GDP for Medical Devices) standards.
• Internal, external and supplier audit management
• Responsible for managing suppliers with the support of supplier quality function.
• Assist with data gathering and analysis for Quality Reviews/Complaint to ensure occurs at required frequency.

Qualifications

Education & Experience

• Degree in pharmacy, science or related discipline is an advantage
• At least 5 years of relevant experience in pharmaceutical, biologics and medical devices in Malaysia
• Regulatory and quality experience (within a healthcare environmentPharmacist License is an advantage
• Well-versed with new registration, license extensions, variations and renewals in Malaysia. Experience with both drugs and medical device registration is an advantage.
• Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations
• Knowledge of regulations and well-versed with changing scope and evolving regulations