Strategic Regulatory Affairs Manager

Private Advertiser; Petaling Jaya; On-site; MYR 180,000 - 260,000; Full time

Job summary

Private Advertiser is seeking a senior Regulatory Affairs professional to lead regulatory strategy and lifecycle management for products across Malaysia and Brunei. The role focuses on developing submission plans, governing dossiers, and ensuring ongoing compliance with regulatory requirements.

You will collaborate with Marketing, BD, and Quality teams, oversee external consultants, and drive regulatory excellence to support product launches and sustainable portfolio growth.

Qualifications

• Bachelor's degree in Pharmacy or related field.
• Registered Pharmacist (preferred where applicable).
• 8–10 years regulatory affairs experience.
• Experience developing regulatory strategies and leading registrations.
• Experience engaging with authorities and industry groups.
• Strong project and stakeholder management skills.

Responsibilities

• Develop and execute regulatory strategies for new products and lifecycle management.
• Lead product registrations, renewals, variations, and maintenance of authorizations.
• Monitor regulatory developments and communicate opportunities/risks.
• Provide regulatory intelligence to regional/global stakeholders.
• Lead cross-functional regulatory workstreams and manage external consultants.
• Drive continuous improvement of regulatory processes and systems.

Skills

Regulatory strategy

Cross-functional leadership

Project management

Stakeholder management

Communication

Regulatory intelligence

Education

Bachelor's in Pharmacy

Registered Pharmacist

Job description

Private Advertiser is seeking a senior Regulatory Affairs professional to lead regulatory strategy and lifecycle management for products across Malaysia and Brunei. The role focuses on developing submission plans, governing dossiers, and ensuring ongoing compliance with regulatory requirements.

You will collaborate with Marketing, BD, and Quality teams, oversee external consultants, and drive regulatory excellence to support product launches and sustainable portfolio growth.