Regional Senior Regulatory Affairs Executive - $4K to $5K
Product Registration and Product Life Cycle management
- 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.
- Maintain medical device dealer licenses and class A licenses (Singapore) on behalf of regional office and support cross-border E-commerce registration initiatives.
- Maintain and upkeep regional regulatory databases.
- Provide legitimate solutions (e.g. reformulation, redressing, commitment letters, bridging reports, etc) to overcome regulatory hurdles, reduce inventory risk and lessen regulatory deficiencies to achieve speed to market
- Establish good rapport and strong working relationships within internal regulatory team, relevant regional stakeholders and Corporate.
- Min Diploma / Bachelor's Degree in Biological Sciences or other relevant courses
- At least 2 years of regional regulatory affairs experience, preferably in medical devices, cosmetics and/ or food/health supplement.
Interested candidates, please forward your resume to [Click Here to Email Your Resume]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
Recruit Express Pte Ltd