Strategic Regulatory Affairs Manager - Malaysia & Singapore

SUN PHARMA; Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

SUN PHARMA in Malaysia is seeking a Regulatory Affairs Manager to lead regulatory strategies and registrations for Malaysia and Singapore, ensuring lifecycle compliance and timely approvals.

The role focuses on serving as regulatory focal point, coordinating with local and regional teams, managing submissions through QUEST3+ and PRISM, and guiding junior staff. Candidates should have 5–8 years of experience in pharma regulatory affairs and a bachelor’s degree in a related field.

Qualifications

• Bachelor’s degree in Pharmacy or related life sciences.
• Minimum 5–8 years of Regulatory Affairs experience in pharmaceutical industry.
• Experience handling submissions in Malaysia and Singapore.
• Working knowledge of QUEST3+ and PRISM.
• Experience with ASEAN CTD dossiers and regulatory authorities.

Responsibilities

• Prepare, review, and submit regulatory applications including new registrations, variations, and renewals.
• Drive timely approvals by managing submission timelines and regulatory risks.
• Develop and implement regulatory strategies to support product launches.
• Act as liaison with NPRA Malaysia and HSA Singapore.
• Maintain regulatory databases, records, licenses and documentation.
• Provide coaching to junior regulatory staff.

Skills

Regulatory affairs

Stakeholder management

Project management

Leadership

Attention to detail

Education

Bachelor's Degree in Pharmacy

Tools

QUEST3+

PRISM

Job description

SUN PHARMA in Malaysia is seeking a Regulatory Affairs Manager to lead regulatory strategies and registrations for Malaysia and Singapore, ensuring lifecycle compliance and timely approvals.

The role focuses on serving as regulatory focal point, coordinating with local and regional teams, managing submissions through QUEST3+ and PRISM, and guiding junior staff. Candidates should have 5–8 years of experience in pharma regulatory affairs and a bachelor’s degree in a related field.