Strategic Regulatory Affairs Leader, Southeast Asia Pharma

AstraZeneca; Selangor; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading pharmaceutical company in Selangor is seeking a Senior Regulatory Affairs Executive to manage regulatory submission strategies for Malaysia and surrounding markets. The position involves ensuring compliance with Good Regulatory Practices and maintaining product licenses. Ideal candidates should have a degree in a bioscience-related field and experience in regulatory submissions, specifically within the Brunei market. This role offers the opportunity to contribute significantly to patient care and the launch of transformative medicines.

Qualifications

• Minimum 2-3 years’ experience in regulatory submissions in the Brunei market.
• Familiarity with pharmaceutical manufacturing quality assurance.

Responsibilities

• Adhere to company and industry ethical codes and Good Regulatory Practices.
• Maintain high standards for product licenses to support business targets.
• Develop regulatory plans for quick and quality approvals.
• Monitor local and global regulatory changes, communicating impacts.

Skills

Experience in Brunei market regulatory submission

Familiarity with quality assurance requirements

Degree in bioscience-related field

Education

Degree or equivalent professional qualification in bioscience

Job description

A leading pharmaceutical company in Selangor is seeking a Senior Regulatory Affairs Executive to manage regulatory submission strategies for Malaysia and surrounding markets. The position involves ensuring compliance with Good Regulatory Practices and maintaining product licenses. Ideal candidates should have a degree in a bioscience-related field and experience in regulatory submissions, specifically within the Brunei market. This role offers the opportunity to contribute significantly to patient care and the launch of transformative medicines.