Regulatory Affairs Manager (Malaysia)

Macleods Pharmaceuticals Sdn Bhd; Kuala Lumpur; On-site; MYR 90,000 - 120,000; Full time

Job summary

A global pharmaceutical company is seeking a Regulatory Affairs Manager in Kuala Lumpur, Malaysia. This high-impact leadership role involves overseeing regulatory affairs activities, managing NPRA submissions, and developing strategies for product launches. The ideal candidate will possess a Bachelor’s or Master’s degree in a relevant field, a minimum of 5–8 years of regulatory experience, and a proven track record in obtaining NPRA approvals. Join us to lead a growing team and advance your career in an international setting.

Benefits

Competitive salary plus benefits

Dynamic work environment

Career progression opportunities

Qualifications

• 5–8 years of regulatory affairs experience in Malaysia.
• Proven track record of NPRA submissions and approvals.
• Strong leadership and decision-making abilities.

Responsibilities

• Lead all regulatory affairs activities for Malaysia.
• Develop regulatory strategies for new product launches.
• Manage NPRA submissions and regulatory compliance.

Skills

Regulatory strategy development

NPRA approvals

Project management

Stakeholder management

Detail-oriented

Communication skills

Education

Bachelor’s or Master’s degree in Pharmacy, Life Sciences or related field

Job description

Macleods Pharmaceutical Sdn Bhd | Full-Time | Immediate Hiring

Macleods Pharmaceutical Sdn Bhd is a global pharmaceutical company expanding its footprint in Malaysia. We are seeking a Regulatory Affairs Manager to lead and oversee all regulatory affairs activities, ensuring timely approvals and compliance with NPRA and Malaysian regulatory requirements.

This is a high-impact leadership role ideal for a candidate with strong NPRA experience and a proven track record in regulatory strategy and submissions.

Key Responsibilities

• Lead and oversee all regulatory affairs activities for Malaysia
• Develop regulatory strategies for new product launches and portfolio expansion
• Manage complex NPRA submissions, variations, renewals, and post-marketing commitments
• Serve as the key contact with NPRA, MOH, and auditors
• Review and approve regulatory sections of labels, inserts, and marketing materials
• Advise management on regulatory risks and compliance matters
• Mentor and guide RA team members
• Ensure regulatory documentation and processes are accurate, timely, and compliant

Requirements

• Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
• Minimum 5–8 years regulatory affairs experience in Malaysia
• Proven track record of NPRA approvals
• Strong leadership, project management, and stakeholder management skills
• Detail-oriented, proactive, and able to make strategic decisions
• Excellent communication skills in English/Malay (both written and verbal)

Why Join Us

• Lead regulatory affairs for a growing international pharmaceutical company
• Exposure to high-impact projects and product launches
• Competitive salary plus benefits
• Opportunity to mentor and grow your regulatory team
• Dynamic work environment with career progression opportunities

Apply now

to join Macleods Pharmaceutical and play a key role in shaping regulatory strategies and ensuring compliance in Malaysia!