Regulatory Pharmacists

Pharmasolution Sdn Bhd; Subang Jaya; On-site; MYR 50,000 - 70,000; Full time

Job summary

A pharmaceutical company in Subang Jaya is seeking an experienced regulatory affairs professional. Responsibilities include preparing product registration dossiers, managing lifecycle activities, and liaising with regulatory bodies. The ideal candidate holds a Bachelor’s Degree in Pharmacy or Life Sciences and is a registered pharmacist. You should possess 2-5 years of regulatory experience, strong analytical skills, and proficiency in English, with Mandarin being a plus. This position offers opportunities for career growth in a dynamic environment.

Qualifications

• Bachelor’s Degree in a relevant field.
• Registered Pharmacist with the Pharmacy Board of Malaysia is preferred.
• 2–5 years of experience in regulatory affairs.

Responsibilities

• Prepare and submit product registration dossiers for pharmaceuticals.
• Manage lifecycle activities including renewals and site transfers.
• Maintain regulatory trackers and databases.

Skills

Regulatory Affairs

Analytical Skills

Organizational Skills

Microsoft Office

English Fluency

Mandarin Proficiency

Education

Bachelor’s Degree in Pharmacy or Life Sciences

Registered Pharmacist (preferred)

Job description

Key Responsibilities

• Regulatory Strategy & Compliance: Prepare and submit product registration dossiers (CTD/ACTD format) for pharmaceuticals and medical devices.
• Manage lifecycle activities including renewals, variations, site transfers, and labeling updates.
• Monitor regulatory changes (NPRA, MDA, ASEAN, ICH) and communicate updates to internal teams.
• Maintain regulatory trackers and databases (e.g., Product Master List, Variation Tracker).
• Ensure timely submission of product licenses and renewals to avoid business disruption.
• Review and approve product labeling, promotional materials, and artwork for compliance.
• Liaise with NPRA, MDA, and other regulatory bodies to facilitate evaluations and approvals.
• Coordinate with internal departments (Sales, QA, R&D, Operations) to align regulatory strategies.
• Respond to regulatory queries, deficiency letters, and post-market surveillance requests.
• Support pharmacovigilance activities including safety documentation and adverse event reporting.
• Assist in SOP development and revision to reflect current regulatory practices.
• Provide strategic input on regulatory pathways for unregistered oncology products under NPP.

Qualifications & Skills

• Bachelor’s Degree in Pharmacy, Life Sciences, Biomedical Science, or related field.
• Registered Pharmacist with the Pharmacy Board of Malaysia (preferred).
• 2–5 years of experience in regulatory affairs or product registration (pharmaceuticals or medical devices).
• Familiarity with NPRA, MDA, PIC/S, and ASEAN regulatory frameworks.
• Strong documentation, analytical, and organizational skills.
• Proficiency in Microsoft Office and regulatory systems.
• Excellent written and spoken English; Mandarin proficiency is an added advantage.
• Detail-oriented, proactive, and able to manage multiple priorities independently.