[ref. c08835004] Regulatory Affairs Executive

Key Responsibilities:

• Regulatory Submissions & Approvals
• Prepare, compile, and submit product registration dossiers to HSA and other relevant regulatory authorities.
• Maintain up-to-date knowledge of Singapore’s Health Sciences Authority (HSA) guidelines, ASEAN Common Technical Dossier (ACTD), and other regional requirements.
• Ensure timely approvals for new product launches, renewals, and variations.
• Compliance & Documentation
• Review product artwork, labels, and promotional materials for compliance with regulatory standards.
• Maintain regulatory databases and ensure that product licenses, certificates, and approvals are current.
• Support internal audits and regulatory inspections (e.g., HSA GMP audits).
• Cross-Department Collaboration
• Work closely with Quality Assurance, R&D, and Production to ensure regulatory compliance throughout the product lifecycle.
• Provide regulatory guidance for new product development and market expansion projects.

• Monitor regulatory changes in Singapore and ASEAN markets and communicate impacts to management.
• Support the development of strategies to address new regulations or compliance risks.

Requirements:

• Bachelor’s degree in any Pharmacy, Life Sciences, Chemistry, or related discipline.
• 2–4 years of hands-on regulatory affairs experience in a pharmaceutical, nutraceutical, or medical device environment.
• Knowledge of HSA regulations, GMP standards, and ACTD/ACTR formats.
• Strong attention to detail, organizational skills, and ability to handle multiple projects.
• Excellent written and verbal communication skills.
• Exposure to end-to-end regulatory processes in a lean, fast-paced company.
• Opportunity to broaden regional regulatory experience (ASEAN and beyond).
• Career path towards Senior RA Executive / Regulatory Affairs Manager as the company grows.

Employees Benefits:

1. Opportunities for growth and development within the pharmaceutical industry.
2. A supportive work environment with a focus on teamwork and efficiency.
3. Annual Leave (e.g., 13–18 days per year)
4. Medical Leave / hospitalizasation Leave
5. Medical & Dental Coverage
6. Insurance Coverage (e.g. Hospitalization)
7. Annual Bonus
8. Annual Company Dinner or Team Bonding Activities
9. Long Service Award