Regulatory Pharmacist

Randstad; Kuala Lumpur; On-site; MYR 60,000 - 80,000; Full time

Job summary

A renowned healthcare distributor is seeking a Regulatory Pharmacist in Kuala Lumpur, Malaysia. This position involves overseeing the performance and compliance of business licenses, certifications, and product registrations. The ideal candidate will have at least 5 years of experience in pharmacy and regulatory affairs, a Bachelor's degree in Pharmacy, and familiarity with auditing standards. This on-site role offers competitive employee compensation and ensures compliance across various regions.

Benefits

Excellent employee compensation and benefits

Qualifications

• Minimum of 5 years of working experience as a pharmacist.
• Proven regulatory and compliance specialization.
• Familiar with registration processes for Medical Devices and Scheduled Poison.

Responsibilities

• Oversee business licenses, certifications, and product registrations.
• Lead application and renewal of business permits.
• Ensure compliance of storage and distribution services.

Skills

Regulatory compliance

Pharmacovigilance

Auditing

Budget management

Education

Bachelor’s degree in Pharmacy

Job description

Job Details

We are currently looking for a Regulatory Pharmacist for one of a renowned healthcare distributor that distribute both medical and pharmaceutical products. This position requires your urgent attention.

• Reporting to: RA Director
• Location: Selangor
• Excellent employee compensation and benefits
• Work Type: On-site

Responsibilities

• Oversee and track performance, manage the overall cost and budget for business licenses, certifications, and product registrations/amendments.
• Lead the application, renewal, and maintenance of all business permits, licenses, and product registrations (including Medical Devices and Pharmaceutical Poison Items) across all regions.
• Lead certification, customer, and supplier audits, oversee compliance of storage and distribution services, and drive QRA continuous improvement projects to standardize processes (GDPMD, SOPs).
• Act as the PIC for Pharmacovigilance (NRPP), conduct PV training, monitor and interpret new guidelines, and provide consolidated monthly status updates across all regions.

Experience & Qualifications

• Bachelor’s degree in Pharmacy and have a minimum of 5 years of working experience as a pharmacist and/or proven regulatory and compliance specialization.
• Familiar with registration processes for Medical Devices, Scheduled Poison & Non-Scheduled Poison, and be familiar with ISO 9001 and GDP/GDPMD audits and compliance requirements.

Education

• Bachelor Degree

How to Apply

Please apply to the job ad above. You are encourage to reach out to Brendan via LinkedIn at https://www.linkedin.com/in/brendan-chan-55477a214/