Regulatory Affairs Executive

4 days ago

Central Region, Singapore Poli Medical Company Pte Ltd Full time $90,000 - $120,000 per year

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.

Regulatory Intelligence

  • 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.

  1. A supportive work environment with a focus on teamwork and efficiency.

  2. Annual Leave (e.g., 13–18 days per year)

  3. Medical Leave / hospitalizasation Leave

  4. Medical & Dental Coverage

  5. Insurance Coverage (e.g. Hospitalization)

  6. Annual Bonus

  7. Annual Company Dinner or Team Bonding Activities

  8. Long Service Award

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