Kerja Sepenuh Masa, Senior Manager Regulatory and Compliance di Apsida Life Science - Maukerja

Title: Regulatory Affairs Manager

Location: Singapore and Malaysia

Duration: 6 months - CAP 155 hours per month

Commitment: (Hybrid / In-office required in the Singapore office)

Company Overview

Apsida Life Science is partnering with an organisation dedicated to community-based clinical trials, ensuring excellent participant care and a smooth transition from hospital to home in accordance with study protocols, clinical practice regulations, and ICH-GCP requirements.

Responsibilities:

• Manage and execute regulatory affairs activities and submissions for Singapore and Malaysia.
• Utilize local health authority systems, specifically requiring an active SingPass log-in for direct access to the Singapore Health Sciences Authority (HSA) portal.
• Manage electronic submissions and regulatory workflows utilizing platforms such as HSA PRISM.
• Ensure all regulatory documentation and dossiers comply with the statutory requirements of the HSA (Singapore) and the National Pharmaceutical Regulatory Agency (NPRA, Malaysia).
• Collaborate cross-functionally to ensure uninterrupted regulatory support and lifecycle management until a permanent full-time employee is placed.

Qualifications:

• Experience: 5+ years of dedicated regulatory affairs experience within the Singapore and Malaysia markets.
• System Expertise: Proven hands-on experience working with HSA PRISM and navigating health authority portals.
• Mandatory Access: Must be a member with an active SingPass login for Singapore Health Authority (HSA) access.
• Language Skills: Fluent in English (written and verbal).

If you are interested in learning more or wish to apply, please reach out to Sweetness Zono at Apsida Life Science: Email: ************* Website: *************

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa), dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process