Senior Regulatory Affairs Executive - Pharma / Cosmetic / Medical Devices

Recruit Express Pte Ltd| Date Posted: 24-Sep-2020
EA Licence No: 99C4599|EA Personal Registration No: R1333338
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

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.

Qualifications/Skills/Experience:

  • 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 or pharmaceutical 

3 openings for Pharmaceutical / Cosmetic / Medical devices portfolio 

MNC 

Interested candidates, please forward your resume to [Click Here to Email Your Resume] 

Consultant: Huang Jingsheng Kevyn (R1333338) 

Recruit Express Pte Ltd (99C4599) 

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