Senior Regulatory Affairs Lead — Brunei, Cambodia & Bangladesh

AstraZeneca (Malaysia); Selangor; On-site; MYR 60,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Senior Regulatory Affairs Executive to oversee regulatory submission strategies for Malaysia, Brunei, Bangladesh, and Cambodia. The role requires at least 2-3 years of experience with a bioscience-related degree and emphasizes compliance and regulatory excellence. Join us in making a difference in healthcare by ensuring high-quality approvals and improving patient access to transformative medicines.

Qualifications

• Minimum 2-3 years’ experience in Brunei market regulatory submission.
• Familiarity with quality assurance requirements within a pharmaceutical manufacturing environment.

Responsibilities

• Adhere to industry codes of conduct and Good Regulatory Practices.
• Maintain product licenses and ensure compliance.
• Develop and implement regulatory plans for approvals.
• Act as key liaison with Health Authorities on regulatory matters.
• Monitor compliance and manage GRP supplier relationships.

Skills

Regulatory submission strategies

Cross-functional teamwork

Compliance management

Communication with Health Authorities

Monitoring regulatory environments

Education

Degree in bioscience-related field

Job description

A leading pharmaceutical company in Malaysia is seeking a Senior Regulatory Affairs Executive to oversee regulatory submission strategies for Malaysia, Brunei, Bangladesh, and Cambodia. The role requires at least 2-3 years of experience with a bioscience-related degree and emphasizes compliance and regulatory excellence. Join us in making a difference in healthcare by ensuring high-quality approvals and improving patient access to transformative medicines.