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Regulatory Affairs Pharmacist

2 weeks ago

Singapore GLORIOUS DEXA SINGAPORE PTE. LTD. Full time

Kick-start your regulatory career while getting meaningful exposure beyond "pure RA." In this role, you'll lead day-to-day product registration and quality management system activities, handle HSA correspondence, and also support SOP/product trainings and occasional product presentations to doctors. It's ideal for a junior pharmacist who wants to build strong RA/QMS fundamentals and also explore cross-functional work with Quality, Supply Chain, and Commercial teams. What you'll do Regulatory Affairs Prepare, submit, and maintain product registration dossiers (new registrations, variations, renewals) via HSA systems; track timelines and respond to authority queries. Coordinate labelling/artwork compliance and change controls with internal and external stakeholders. Maintain RA trackers, licenses, and product records; ensure documentation is inspection-ready. Quality & QMS (GDP alignment)Support implementation and maintenance of the Quality Management System, including document control, training records, deviations/CAPA, and self-inspections. Assist with complaint handling, product returns/recalls, and oversight of suppliers/customers for lawful supply; keep accurate records of delegated duties. Partner with logistics/principals to ensure GDP compliance across warehousing and distribution. Training & Cross-functional Support (additional exposure)Coordinate and deliver internal SOP/QMS refreshers and product trainings. Prepare materials and occasionally conduct internal product trainings for marketing team as well as product presentations to doctors in collaboration with Medical/Commercial teams (minor but valuable portion of the role). What you'll bring Registered Pharmacist with the Singapore Pharmacy Council (SPC) (required). 0–2 years' experience in RA/QMS (fresh graduates welcome); familiarity with HSA guidelines and e-services is a plus. Working knowledge or interest in GDP, QMS, CAPA, pharmacovigilance, and inspection readiness. Clear, professional communication; strong organization and follow-through across multiple stakeholders. Comfort presenting scientific/product content to internal teams and HCPs (training provided). What you'll gain End-to-end exposure across Regulatory Affairs + Quality, with hands‐on training and mentorship. Cross‐functional experience (Medical, Supply Chain, Commercial) and the opportunity to build a well‐rounded pharma skill set early in your career. #J-18808-Ljbffr