Regulatory Affairs Specialist

Bright Prospect; Selangor; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading life sciences company in Petaling Jaya, Selangor, is seeking a candidate for a Regulatory Affairs position. The role involves preparing regulatory submissions, managing license maintenance, and ensuring compliance with regulations. Ideal applicants should have a Bachelor's degree in Pharmacy or related fields, with some experience in Regulatory Affairs being preferred. Fresh graduates are also encouraged to apply. Strong communication and project management skills are essential for success in this position.

Qualifications

• Bachelor’s degree in Pharmacy or a related Life Sciences field required.
• 1–2 years of work experience in Regulatory Affairs preferred.
• Fresh graduates are welcome to apply.

Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registrations.
• Manage labeling revisions and CMC updates for licenses.
• Respond to queries from regulatory authorities.

Skills

Detail-oriented

Strong communication skills

Project management skills

Adaptability

Proactivity

Education

Bachelor’s degree in Pharmacy or related Life Sciences

Job description

Job Overview

Location: Petaling Jaya, Selangor

Responsibilities

• 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.

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 able to multitask.
• Strong communication and project management skills.
• Proactive, independent, adaptable, and self‑motivated.

How to Apply

Send resume to:
Recruitment Consultant: Wei Li
Email: *****@brightprospect.com.my