Regulatory Affairs jobs in Malaysia

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.

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.

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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