Regulatory Affairs Specialist -NPRA (SEA)

Regulatory Affairs Specialist -NPRA (SEA)

Salary : RM 3,500 – RM 5,500 + benefit + 1 month bonus

Note : Experience in Regulatory Operation and submission for NPRA, particularly within Southeast Asia, is an advantage. End‑to‑end submission knowledge for NPRA is required.

Overview

The Regulatory Project Specialist supports regulatory affairs for new and in‑line products in the country. Responsibilities include submissions for marketing authorization transfer, new product registration, variations, and miscellaneous applications such as ad‑hoc requests, permits and special exemptions. The role ensures registration requirements are fulfilled promptly to facilitate product commercialization.

Responsibilities

• Develop registration strategies, prioritize assignments, and implement regulatory plans aligned with company objectives.
• Submit marketing authorization transfers and related post‑approval submissions.
• Expedite product commercialization by ensuring timely registration approvals.
• Review, analyze, and provide feedback on new product submissions and post‑approval maintenance.
• Coordinate closely with stakeholders to execute strategic regulatory plans across Pfizer’s portfolio.
• Manage labeling and artwork changes to maintain compliance and timely implementation.
• Review and approve consumer medicine information, packaging labels, promotional material, and other documentation for regulatory compliance.
• Support product license maintenance and resolve related regulatory issues.
• Assist with production and manufacturing issues, including submission negotiations, sourcing, packaging, and compliance matters.
• Monitor regulatory changes and promptly update relevant departments.
• Maintain accurate records in Pfizer Systems, ensuring timely updates per SOP.
• Report monthly on approval activities, inquiries, filings, and launch performance against timelines and budgets.
• Provide administrative support for poison license and clinical trial maintenance activities, where applicable.
• Maintain effective communication and collaboration with internal functions (GCMC, RegOps, PGS, Commercial, Medical, etc.).
• Participate in negotiations with regulatory authorities and industry associations.
• Support inventory coordination for local market stock availability aligned with product launches.
• Advise on promotional materials and marketing plans to ensure regulatory alignment.
• Ensure compliance of records and systems per local and international regulations and Pfizer SOPs.
• Coordinate product recall activities with sales, marketing, logistics, and distributors when required.

Qualifications

Skills

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