Regulatory Affairs Executive
3 days ago
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.
A supportive work environment with a focus on teamwork and efficiency.
Annual Leave (e.g., 13–18 days per year)
Medical Leave / hospitalizasation Leave
Medical & Dental Coverage
Insurance Coverage (e.g. Hospitalization)
Annual Bonus
Annual Company Dinner or Team Bonding Activities
Long Service Award
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