Regulatory Affairs Executive

Range Pharma Sdn Bhd; Kuala Lumpur; On-site; MYR 60,000 - 120,000; Full time

Job summary

Range Pharma Sdn Bhd is seeking a Regulatory Affairs professional to handle registration and renewals with local and overseas authorities. You will compile dossiers, follow up on approvals, and ensure documentation stays compliant and market-ready.

The role involves coordinating with departments, liaising with authorities and suppliers, and applying for GMP, CPP, and Certificate of Free Sale as needed. A fast-moving environment requires sharp attention to detail and proactive problem-solving.

Qualifications

• 1–3 years in regulatory affairs, pharmaceutical experience preferred
• Open to candidates from medical device, food, or supplement registration (relevant scope)
• Bonus: experience with DVS registration, biologics, or vaccines
• Sharp attention to detail, strong critical thinking, and disciplined with documentation
• Able to keep pace in a fast-moving environment

Responsibilities

• Prepare, compile, and submit registration and renewal dossiers to local and overseas authorities
• Follow up on registration correspondence and respond to authority queries
• Coordinate packaging and marketing materials for compliance and accuracy
• Liaise with authorities, suppliers, and internal teams on regulatory matters
• Apply for GMP, CPP, and Certificate of Free Sale as needed
• Keep the regulatory archive up-to-date and stay current on regulations

Skills

Regulatory affairs

Dossier compilation

Attention to detail

Cross-functional coordination

Education

Bachelor's degree in Pharmacy

Job description

About the Role

Handle product registration and renewals with local and overseas authorities — from compiling dossiers to following up on approvals. You'll keep our regulatory records tight, coordinate across departments, and make sure our products stay compliant and market-ready.

What You'll Do

• Prepare, compile, and submit registration and renewal dossiers to local and overseas authorities
• Follow up on registration correspondence and respond to authority queries
• Coordinate packaging and marketing materials for compliance and accuracy
• Liaise with authorities, suppliers, and internal teams on regulatory matters
• Apply for GMP, CPP, and Certificate of Free Sale as needed
• Keep the regulatory archive up-to-date and stay current on regulations

• Degree in Pharmacy, Pharmaceutical Science, Chemistry, Biology, Science, or related field
• 1–3 years in regulatory affairs — pharmaceutical experience strongly preferred
• Open to candidates from medical device, food, or supplement registration (relevant scope)
• Bonus: experience with DVS registration, biologics, or vaccines
• Sharp attention to detail, strong critical thinking, and disciplined with documentation
• Able to keep pace in a fast-moving environment