Snr Regional Regulatory Affairs Executive (Health Supplement/Medical Device) **IMMEDIATE**

• Regional Lead in new registration submissions and life cycle management projects of medical devices, food/health supplements, and cosmetics in APAC regions. Examples for life cycle projects include technical variations (such as change in manufacturer, formulation change, etc).
• Regional Lead in regulatory-status re-classification projects to serve commercial marketing needs.
• Timely management and execution of registration activities for assigned product portfolios, responsible to monitor and provide update of project progress to completion to stakeholders.
• Work closely with manufacturers and country regulatory teams for prompt response to submission queries, ability to analyze and identify gaps to address Authority needs.
• Review and approve artwork for Asia Pacific with base knowledge of labelling requirements in individual countries according to in-house artwork system, ability to address and resolve labeling issues when required.
• Establish good rapport and strong working relationships within internal regulatory team, relevant regional stakeholders and Corporate.
• Comply with regional and corporate regulatory and quality SOPs and policies, support regulatory compliance activities such as audits, licensing due diligence checks.
• Assess regulatory viability of bringing EU-approved products with country regulatory affairs by reviewing data such as formulation, intended use, clinical, safety and manufacturing data and highlighting gaps and resolutions
• Other ad-hoc duties requested time from time from superior/cross-functional colleagues

Requirements:

• Possess at least a Bachelor's Degree in Biological Sciences
• At least 2 years of regional regulatory affairs experience, preferably in medical devices, cosmetics and/ or food/health supplement.
• Details orientated, ability to multi-task, self-motivate, show persistence and resilience in overcoming challenges
• Able to assimilate complex and extensive information and condense it for management decisions
• Good project management skills (competent in analytical, written, presentation and communication skills).
• Able to start work immediately or on short notice

Interested candidate,  kindly send a copy of your resume to: [Click Here to Email Your Resume]

Jessica Fong Zhi Tong
CEI Registration No.: R1879124
EA Licence No.: 99C4599