Senior Regulatory Affairs Strategist

AstraZeneca (Malaysia); Selangor; On-site; MYR 120,000 - 180,000; Full time

Job summary

AstraZeneca in Malaysia is seeking a Regulatory Affairs professional to develop and implement regulatory strategies enabling rapid approvals and launches for new products and growth platforms. The role emphasizes maintaining licences, monitoring regulatory changes, and coordinating with cross-functional teams and Health Authorities.

Ideal candidates will have 2–3 years of experience in Malaysia regulatory submissions, a bioscience degree, and familiarity with pharmaceutical QA standards.

Qualifications

• A degree or equivalent in bioscience is required.
• 2–3 years' experience in Malaysia market regulatory submission.
• Familiar with quality assurance requirements within a pharmaceutical manufacturing environment.

Responsibilities

• Develop and implement regulatory strategies to achieve rapid and high quality approvals and facilitate rapid launch for new products and growth platforms.
• Maintain existing Product Licences with no negative impact on business objectives and financial targets.
• Monitor and interpret local and global regulatory changes and communicate implications to key stakeholders.
• Manage local and global regulatory support systems/information for coordination with stakeholders.
• Contribute to cross-functional teamwork to support optimal business strategies.
• Aid in building an effective Regulatory Team.
• Adhere to AZ and Industry Codes of Conduct, ethics, PhAMA Code and GRP, ensuring high regulatory standards.
• Develop strong relationships with Health Authorities and regulatory KEEs.
• Ensure regulatory activities comply with AZ Good Regulatory Practice.

Skills

Regulatory submissions

Quality assurance

Education

Bioscience degree

Job description

AstraZeneca in Malaysia is seeking a Regulatory Affairs professional to develop and implement regulatory strategies enabling rapid approvals and launches for new products and growth platforms. The role emphasizes maintaining licences, monitoring regulatory changes, and coordinating with cross-functional teams and Health Authorities.

Ideal candidates will have 2–3 years of experience in Malaysia regulatory submissions, a bioscience degree, and familiarity with pharmaceutical QA standards.