Senior Regulatory Affairs Specialist – Greater Asia
On-siteSingapore, Singapore
Singapore, SingaporeOn-siteFull TimeSenior LevelLarge
Full TimeSenior LevelLarge
Job Summary
Design and execute project plans to secure product approvals while identifying and escalating regulatory risks early. Compile, prepare, and submit registrations, renewals, variations, and change notifications to authorities in Singapore and Malaysia. Respond to regulatory inquiries within strict timelines, review labeling for compliance, and manage post-market surveillance and complaints. Own regulatory databases, participate in audits, and share intelligence with business units to support continuous improvement initiatives.
Required Qualifications
- A degree in Pharmacy, Health Sciences, or equivalent
- Minimum 5 years of regulatory experience in medical devices
- Proven expertise in new registrations, license extensions, variations, and renewals
- Mandatory experience in Class II devices and above
- Strong knowledge of regulatory laws, acts, and evolving requirements
- Solid understanding of GDPMD standards
- Skills in project management, multitasking, and prioritization
- Excellent interpersonal, communication, and negotiation abilities
- Proficiency in technical systems (word processing, spreadsheets, databases, online research)
- Ability to identify compliance risks and escalate effectively
Desired Qualifications
- Experience with RIM systems is an advantage
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