Regulatory Affairs Manager

Businesslist; Kuala Lumpur; On-site; MYR 120,000 - 180,000; Full time

Benefits offered by this job

Fast-growing organization

Competitive salary

Salary plus allowances

Positive working culture

Job summary

Businesslist is seeking an experienced Regulatory Affairs Manager in Kuala Lumpur to lead registrations and ensure compliance with NPRA and GDP.

You will prepare regulatory documentation, coordinate with internal teams, maintain files, review labels, and monitor regulatory changes to support business operations.

The role offers growth in a fast-growing organization with competitive salary and allowances, and a positive working culture.

Qualifications

• Bachelor's Degree in Pharmacy, Biomedical or relevant education background.
• Strong knowledge of regulatory requirements in the pharmaceutical industry.
• Experience with NPRA regulations and submissions and GDP requirements.
• Experience with regulatory submissions and product registrations.
• Attention to detail and the ability to manage documentation accurately.
• Excellent communication and organisational skills.

Responsibilities

• Prepare and submit regulatory documentation to relevant authorities for product approvals.
• Ensure compliance with local and international regulatory guidelines and standards.
• Maintain and update regulatory files and databases.
• Coordinate with internal teams to support product registration processes.
• Provide regulatory advice and updates to support business operations.
• Monitor changes in regulatory requirements and ensure timely implementation.
• Develop and maintain relationships with regulatory bodies and agencies.
• Review and approve product labels and marketing materials for compliance.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Organisational skills

Education

Bachelor's degree in Pharmacy, Biomedical or related

Job description

Responsibilities

• Prepare and submit regulatory documentation to relevant authorities for product approvals.
• Ensure compliance with local and international regulatory guidelines and standards.
• Maintain and update regulatory files and databases.
• Coordinate with internal teams to support product registration processes.
• Provide regulatory advice and updates to support business operations.
• Monitor changes in regulatory requirements and ensure timely implementation.
• Develop and maintain relationships with regulatory bodies and agencies.
• Review and approve product labels and marketing materials for compliance.

Successful Applicant

A successful Regulatory Affairs Manager should have:

• Bachelor's Degree in Pharmacy, Biomedical or relevant education background.
• Strong knowledge of regulatory requirements in the pharmaceutical industry.
• Strong experience with NPRA regulations and submissions and handling GDP requirements.
• Experience with regulatory submissions and product registrations.
• Attention to detail and the ability to manage documentation accurately.
• Excellent communication and organisational skills.

Benefits

• Opportunity to work in a fast-growing and stable organization.
• Competitive annual salary.
• Basic salary plus additional allowances.
• Positive working culture.