Regulatory Affairs Executive

Delfi; Subang Jaya; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading company in healthcare is seeking a Regulatory Affairs Specialist in Subang Jaya, Malaysia. The successful candidate will prepare, review, and submit regulatory applications to authorities while ensuring compliance with local regulations. Candidates should possess a Bachelor’s Degree in a related field and have strong analytical skills along with attention to detail. Experience in regulatory affairs is preferred, but motivated fresh graduates may apply. This role requires effective communication skills and the ability to handle multiple tasks independently.

Qualifications

• 2–3 years of regulatory affairs experience preferred (fresh graduates may be considered).
• Ability to understand and interpret regulatory guidelines.
• Knowledge of regulatory guidelines for pharmaceuticals, medical devices, and/or food products preferred.

Responsibilities

• Prepare and submit regulatory applications to authorities.
• Monitor and track submission progress and approvals.
• Maintain up-to-date regulatory documentation and records.

Skills

Attention to detail

Analytical skills

Strong written and verbal communication

Document filing and record management

Education

Bachelor’s Degree in Science, Pharmacy, Biotechnology, or related field

Job description

Prepare, review, and submit regulatory applications to regulatory authorities.

Monitor and track submission progress, approvals, renewals, and variations.

Maintain up-to-date regulatory documentation, records, and filing.

Review product labels, artworks, and related materials for regulatory compliance.

Conduct routine literature searches for safety updates and maintain post‑market safety documentation.

Monitor regulatory changes and ensure continued compliance with local regulations.

Requirements

• Bachelor’s Degree in Science, Pharmacy, Biotechnology, or a related field.
• 2–3 years of regulatory affairs experience preferred (strongly motivated fresh graduates may also be considered).
• Ability to understand and interpret regulatory guidelines and technical documents with strong analytical skills.
• Excellent attention to detail and proficiency in document filing and record management.
• Strong written and verbal communication skills.
• Self‑motivated, responsible, and able to manage multiple tasks and meet deadlines independently.
• Knowledge of regulatory guidelines for pharmaceuticals, medical devices, cosmetics, and/or food products (preferred).
• Familiarity with pharmacovigilance and post‑market surveillance processes is a plus.