Snr Regional Regulatory Affairs Executive (Health Supplement/Medical Device) **IMMEDIATE**
Recruit Express Pte Ltd| Date Posted: 23-Dec-2020
EA Licence No: 99C4599|EA Personal Registration No: R1879124
Bachelor's / Honours
- 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
- 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
Recruit Express Pte Ltd