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Job Details

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Regulatory Affair Manager

EmployerOne Co.
Singapore, North, Woodlands
On-site
FULL_TIME
SGD 4,500 - 6,000 per month
3 to 5 Years
Posted 14 April 2026
Immunology: Inflammatory Bowel Disease Clinical Trial Phase I, II, III Test JobPost90
Job Reference No.: 2457737   |   Published 3 month ago

Job Description

  • Disclaimer  Pre-Launch Test Posting Notice

    The Regulatory Affairs Officer is responsible for supporting regulatory submission activities and ensuring that products comply with applicable local and international regulatory requirements within the pharmaceutical, biotechnology, medical device, or healthcare industry. The role involves preparing, reviewing, and maintaining regulatory documentation for product registrations, variations, renewals, and compliance activities while coordinating with internal departments and external regulatory authorities. The candidate will assist in monitoring evolving regulatory guidelines and ensuring that organizational processes, product documentation, labeling, and submissions remain aligned with current regulatory standards and industry requirements.

    The successful candidate will work closely with cross-functional teams including Quality Assurance, Medical Affairs, Clinical Operations, Manufacturing, Supply Chain, and Commercial teams to support timely regulatory approvals and product lifecycle management activities. Responsibilities may include compiling dossiers, maintaining regulatory databases, supporting audits and inspections, tracking submission timelines, and communicating with health authorities regarding regulatory queries or approvals. The ideal candidate should possess strong organizational, analytical, and documentation skills, with attention to detail and the ability to manage multiple projects simultaneously. Prior experience in regulatory affairs, healthcare compliance, or pharmaceutical documentation management will be advantageous, particularly within regulated healthcare environments.

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Closing Date: 14 April 2027