Regulatory Pharmacists

3 days ago

Subang Jaya Selangor, Malaysia PHARMASOLUTION SDN BHD Full time

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.

Documentation & Submission

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.

Stakeholder Engagement

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.

Operational Oversight

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.

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