Regulatory Affairs Executive

Dexchem Industries Sdn Bhd; Seberang Perai; On-site; MYR 50,000 - 70,000; Full time

Job summary

A prominent animal pharmaceuticals company in Penang is seeking a Regulatory Affairs Executive to manage product registrations and ensure compliance with regulatory authorities. Responsibilities include preparing regulatory dossiers for NPRA and DVS, liaising with authorities, and monitoring regulatory updates. Candidates must possess hands-on experience in NPRA and DVS registration, a strong understanding of GMP requirements, and excellent communication skills. This role requires the ability to independently manage regulatory projects and effectively solve problems related to regulatory issues. Competitive compensation and a dynamic work environment are offered.

Qualifications

• Mandatory experience in NPRA and DVS registration.
• Understanding of GMP requirements for animal pharmaceuticals.
• Experience in preparing regulatory dossiers.

Responsibilities

• Manage registration, renewal, and variation of animal pharmaceutical products.
• Prepare and submit regulatory dossiers to NPRA and DVS.
• Liaise with regulatory authorities and ensure compliance.

Skills

Hands-on experience in NPRA and DVS registration

GMP requirements understanding

Regulatory dossier preparation

Strong organizational skills

Time management skills

Problem-solving abilities

Excellent written communication

Excellent verbal communication

Tools

QUEST 3+ system

Job description

We are seeking a Regulatory Affairs Executive to manage regulatory submissions and ensure compliance for our animal pharmaceutical manufacturing operations. The successful candidate will be responsible for product registration with regulatory authorities and supporting GMP-related regulatory activities.

Job Description

Handle registration, renewal, and variation of animal pharmaceutical products with NPRA and Department of Veterinary Services (DVS).

Prepare, compile, and submit complete regulatory dossiers in accordance with NPRA and DVS requirements.

Liaise with NPRA, DVS, and other relevant authorities on regulatory matters, queries, and follow-ups.

Ensure products comply with Malaysian regulatory guidelines, standards, and applicable laws.

Monitor regulatory updates, guideline changes, and new requirements, and provide regulatory advice to internal teams.

Maintain and manage regulatory documentation, records, and databases.

Support GMP-related regulatory inspections and audits, including preparation of regulatory documents and coordination of responses to authority findings.

Able to independently resolve regulatory-related problems and respond to regulatory queries effectively.

Qualifications

Hands-on experience in NPRA and DVS registration is mandatory.

Good understanding of GMP requirements and regulatory compliance for animal pharmaceuticals.

Experience in regulatory dossier preparation, submission processes, and correspondence with regulatory authorities.

Strong organizational, documentation, and time management skills.

Able to work independently and manage multiple regulatory projects simultaneously.

Experience using the QUEST 3+ system for regulatory registration submissions is essential.

Excellent written and verbal communication skills.

Strong problem-solving and analytical abilities.

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