Senior Regulatory Strategy Lead — Pharma

AstraZeneca plc; Petaling Jaya; On-site; MYR 120,000 - 180,000; Full time

Job summary

AstraZeneca plc in Malaysia is seeking a Regulatory Affairs professional to develop and implement strategies for rapid product approvals and launches, while maintaining existing licences and compliance. The role requires 2–3 years of local submission experience, QA familiarity, and the ability to build strong relationships with health authorities and cross-functional teams.

Join a global leader committed to high regulatory standards and ethical practices, with opportunities to grow within the

Qualifications

• Degree or equivalent professional qualification in bioscience related field.
• Min. 2-3 years’ experience in Malaysia market regulatory submission.
• Familiar with QA requirements within pharmaceutical manufacturing.

Responsibilities

• Develop and implement regulatory strategies to enable rapid approvals and launches.
• Maintain existing Product Licences with no negative impact on business targets.
• Monitor local and global regulatory changes and communicate implications to stakeholders.
• Manage regulatory support systems and coordinate with stakeholders.
• Foster cross-functional teamwork to support business strategies.
• Build an effective Regulatory Team.
• Ensure compliance with AZ GRP and industry codes, maintaining high regulatory standards.
• Develop strong relationships with Health Authorities and KEEs.

Skills

Regulatory submissions experience

Quality assurance knowledge

Cross-functional teamwork

Regulatory compliance

Education

Degree or equivalent in bioscience

Job description

AstraZeneca plc in Malaysia is seeking a Regulatory Affairs professional to develop and implement strategies for rapid product approvals and launches, while maintaining existing licences and compliance. The role requires 2–3 years of local submission experience, QA familiarity, and the ability to build strong relationships with health authorities and cross-functional teams.

Join a global leader committed to high regulatory standards and ethical practices, with opportunities to grow within the