Regulatory Affairs Specialist

Location: Petaling Jaya, Selangor

Job Descriptions:

• Prepares, compiles, and submits regulatory dossiers for new product registrations, renewals, and post-approval variations.
• Ensures timely maintenance of product licenses by managing labeling revisions and CMC (Chemistry, Manufacturing, and Controls) updates.
• Handles and responds to queries from regulatory authorities, while monitoring and tracking submission status to ensure compliance timelines are met.
• Collaborates closely with cross-functional teams to ensure alignment and consistency across regulatory, quality, and commercial activities.
• Stays up to date with local and international regulatory requirements to ensure the company remains compliant.
• Supports audits and inspections by maintaining accurate, well-organized, and up-to-date regulatory documentation.
• Provides support in additional regulatory projects and acts as a Subject Matter Expert (SME) to lead or contribute to the implementation of internal processes or systems.

Job Requirements:

• A Bachelor’s degree in Pharmacy or a related Life Sciences field.
• 1-2 years of work experience in Regulatory Affairs
• Fresh graduates are welcome to apply
• Detail-oriented, well-organized and multitask.
• Strong communication and project management skills.
• Proactive, independent, adaptability, and self-motivated.

Others Information:

For those who have what it takes, please send in resume to:
Recruitment Consultant : Wei Li
Email: weili@brightprospect.com.my