Assistant Regulatory Affairs Manager

Michael Page; Kuala Lumpur; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Allowances

Positive culture

Job summary

Michael Page is partnering with a well-established pharmaceutical company in Malaysia to recruit a Regulatory Affairs Manager. The role focuses on leading NPRA registrations, ensuring regulatory compliance, and coordinating with internal teams to support product registrations.

The successful candidate will possess a Bachelor's degree in Pharmacy or related fields with strong NPRA knowledge, regulatory submissions experience, and excellent communication skills.

Qualifications

• 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.

Responsibilities

• Lead end-to-end NPRA registrations with regional exposure.
• 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.

Education

Bachelor's Degree in Pharmacy, Biomedical or relevant education background

Job description

• Lead end-to-end NPRA registrations with regional exposure.
• Join a fast-growing and stable pharma company.

About Our Client

A well established pharmaceutical company with strong regional presence.

Job Description

• 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.

The 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.

What's on Offer

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