Disclaimer  Pre-Launch Test Posting Notice

About the Role

The Senior Regulatory Affairs Officer supports product submissions, ensures regulatory compliance, maintains licenses, and coordinates communication with local health authorities such as HSA (Health Sciences Authority). The role requires strong attention to detail, deep understanding of regulatory pathways, and excellent cross-functional collaboration.

Key Responsibilities

• Prepare, review, and submit regulatory applications for new products, renewals, variations, and post-market changes.

• Maintain up-to-date product registrations, listings, and regulatory documentation in compliance with HSA guidelines.

• Ensure product labels, IFUs, artwork, and marketing materials comply with regulatory requirements.

• Coordinate responses to queries from regulators and support audits or inspections.

• Monitor regulatory changes, guidelines, and emerging policies affecting the business.

• Provide regulatory guidance to internal teams (Quality, R&D, Supply Chain, Marketing).

• Support product lifecycle management, including changes to formulation, packaging, and manufacturing.

• Review technical dossiers, quality documentation, and clinical evidence to ensure accuracy.

• Lead or support regulatory aspects of product launches and market expansions.

• Assist in maintaining SOPs, documentation systems, and compliance frameworks.

Requirements

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Science, Chemistry, or related fields.

• Minimum 4–7 years of regulatory affairs experience in pharmaceuticals, biologics, nutraceuticals, or medical devices.

• Strong familiarity with HSA regulations, ASEAN CTD, GDPMDS, PIC/S GMP, or relevant global guidelines.

• Experience in dossier preparation, product submissions, and license management.

• Strong analytical, documentation, and communication skills.

• Ability to manage multiple submissions, deadlines, and cross-functional stakeholders.

Preferred Attributes

• Detailed-oriented and meticulous in reviewing technical documents.

• Strong initiative in monitoring regulatory developments and assessing business impact.

• Ability to work independently while supporting team-wide objectives.

• Prior experience supporting audits, product recalls, or compliance investigations is advantageous.

This job posting is currently published for testing and platform validation purposes during the pre-launch phase of MedicalHealthcareJobs.com, a platform developed to support the global Healthcare and Life Sciences recruitment ecosystem. Visitors may also stay updated with the latest industry news through our website while additional employers, recruiters, and opportunities are progressively onboarded.

Healthcare professionals are encouraged to sign up as a Jobseeker and start building their career profiles while we gradually onboard employers and recruiters to bring more opportunities to the platform.

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Feedback and suggestions are welcome at [email protected].