Regulatory Affairs Manager

Responsibilities

• Develop and implement regulatory strategies for assigned therapeutic areas to achieve high-quality approvals and facilitate rapid product launches in Malaysia.
• Maintain product licenses to a high standard, ensuring zero negative impact on business objectives and financial targets.
• Monitor and interpret local and global regulatory environments for significant changes and communicate implications to key stakeholders.
• Build and maintain excellent relationships and partnerships with Health Authorities and regulatory Key External Experts (KEEs).
• Act as the Company Pharmacist and Poison A License holder for the company.
• Manage regulatory vendors, suppliers, and legal or patent-related matters in accordance with company requirements.
• Provide functional support and guidance to regulatory team members.
• Ensure all activities adhere to industry codes of conduct, ethics, PhAMA code, and Good Regulatory Practices.

Requirements

• Pharmacy or Scientific Degree (or equivalent professional qualification in a related field).
• Minimum of 5 years of experience in the regulatory affairs field.
• Post-graduate qualification.

About the Company

AstraZeneca is a forward-thinking BioPharmaceutical company dedicated to helping patients all over the world by delivering life-changing medicines. We operate as one collaborative team, fostering an inclusive and diverse environment where innovation and creativity drive our success.