Regulatory Affairs Executive (West Region | DMF, CEP, GMP)

HRnet One Pte Ltd; Singapore; On-site; SGD 50,000 - 80,000; Full time

Job summary

A multinational manufacturing firm in Singapore is seeking an experienced Regulatory Affairs Executive to prepare and maintain regulatory documents, ensure compliance with GMP standards, and support regulatory activities. The ideal candidate will have a Bachelor’s Degree in a relevant field and 2-4 years of experience in Regulatory Affairs or Compliance. Strong documentation and communication skills are essential. Interested candidates are encouraged to apply directly or send their resume.

Qualifications

• 2-4 years of experience in Regulatory Affairs, Quality, or Compliance within a GMP-regulated environment.
• Working knowledge of PIC/S GMP, ICH Q-series, and relevant international standards.
• Exposure to DMF, CEP, and country-specific registrations is an advantage.

Responsibilities

• Prepare, compile, and maintain regulatory documentation for product registrations.
• Coordinate responses to customer regulatory queries and documentation requests.
• Maintain accurate and compliant regulatory files, records, and declarations.
• Support regulatory compliance activities including change impact assessments.

Skills

Regulatory Affairs

Quality Compliance

Documentation Skills

Analytical Skills

Organizational Skills

Time Management

Communication

Education

Bachelor’s Degree in Chemistry, Pharmacy, Life Sciences, or a related discipline

Job description

Overview

Our client is a well-established multinational manufacturer within the chemical and pharmaceutical ingredients industry in Singapore. They are currently seeking a Regulatory Affairs Executive to support and lead the following responsibilities:

Responsibilities

• Prepare, compile, and maintain regulatory documentation for product registrations and customer submissions (e.g. DMF, CEP).

• Coordinate responses to customer regulatory queries and documentation requests with QA, QC, and Operations teams.

• Maintain accurate and compliant regulatory files, records, and declarations in line with GMP requirements.

• Support regulatory compliance activities, including change impact assessments, CAPAs, audit readiness, and tracking submissions and timelines.

Qualifications

• Bachelor’s Degree in Chemistry, Pharmacy, Life Sciences, or a related discipline, with 2–4 years of experience in Regulatory Affairs, Quality, or Compliance within a GMP-regulated environment.

• Working knowledge of PIC/S GMP, ICH Q-series, and relevant international standards; exposure to DMF, CEP, and country-specific registrations is an advantage.

• Strong attention to detail with excellent documentation, analytical, organizational, and time-management skills.

• Effective communicator who is proactive, reliable, able to work independently, and collaborates well across teams.

Interested professionals with the above experience and skill sets are encouraged to apply directly or send a detailed resume to: [e-mail]