Regulatory Affairs Manager (6-Month Maternity Cover)

About the role

This is a 6-month maternity cover position for a Regulatory Affairs Manager in Singapore. The role leads regulatory, medical affairs and quality-related activities and ensures full regulatory compliance, working closely with country leadership and regional/regroup Regulatory Affairs to deliver compliant submissions, support promotional and medical compliance and coordinate quality and GxP interfaces with regional QA and supply chain functions.

Key responsibilities

• Manage new product registrations, variations and notifications in Singapore, and maintain product licences and regulatory trackers
• Handle advertisement and sales promotion permit submissions and review and approve artwork in Veeva, coordinating with Supply Chain and SG Commercial
• Manage similar registrations, variations and renewals through a third-party distributor in Brunei, and coordinate artwork compliance and exemption requests
• Review and approve promotional materials and external communications for regulatory and medical compliance, and manage pharmacovigilance reporting in Singapore, including compiling quarterly adverse events from the HSA database
• Ensure GDP compliance for therapeutic product wholesaler and importer licences, take part in internal audits and mock recalls, and oversee product redress and complaints

Required profile

• Minimum 4-5 years of pharmaceutical industry experience in Singapore (essential)
• Pharmacy, medical or relevant science degree with good pharmacological/pharmaceutical chemistry/clinical knowledge (essential)
• Current Singapore pharmacist licence or registration (preferred)
• Post-graduate qualification in regulatory science, quality or life sciences (desirable)

Required skills

• Knowledge of Singapore's regulatory environment and advertisement and sales promotion regulations
• Familiarity with traditional medicines, health supplements, cosmetics, medical devices and food product regulation is a bonus
• Strong project management and organisational skills
• Attention to detail, communication and technical writing skills; ability to work independently and with stakeholders