Experience

Consultant indépendant

• Technology, Information and Internet
• 300 - 400 Employee

• Regulatory Consultant

  • Aug 2016 - Present

  Manage New Registration Product and Existing Product (Variation changes or renewal registration) : - food & beverage - food supplement & traditional medicine - cosmetic - medical devise and - house hold product. Manage claim, artwork development and Advertisement claim review. Manage dossier, trackwise system and any docs related the compliance of registration. Approaching BOH and MOH for regulatory matters. Halal registration Responsible for Apoteker Penanggung Jawab Teknis Show less



Reckitt

• United Kingdom
• Manufacturing
• 700 & Above Employee

• Regulatory Manager

  • Jan 2013 - Apr 2014

  Approaching BOH and MOH for regulatory matters, Manage NPD and EPD for House Hold and Cosmetic Product. Manage registration, claim and artwork development review. Manage dossier and trackwise system. Responsible for Penanggung Jawab Teknis for Cosmetic Product, Manage and report the MESO of cosmetic and house hold product. Approaching BOH and MOH for regulatory matters, Manage NPD and EPD for House Hold and Cosmetic Product. Manage registration, claim and artwork development review. Manage dossier and trackwise system. Responsible for Penanggung Jawab Teknis for Cosmetic Product, Manage and report the MESO of cosmetic and house hold product.



GSK

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs

  • Jan 2010 - Jan 2013

  Review new product development refer to government regulations; Product dossier collection from R&D and QA to be submitted to BOH; Claim review of new product refer to claim study report; Lab Test Result review refer to Government regulations; Artwork claim review based on BOH approval; Advertisement claim review before release to market; Change control to any new product and product changing. Review new product development refer to government regulations; Product dossier collection from R&D and QA to be submitted to BOH; Claim review of new product refer to claim study report; Lab Test Result review refer to Government regulations; Artwork claim review based on BOH approval; Advertisement claim review before release to market; Change control to any new product and product changing.



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Apprentice

  • Oct 2009 - Dec 2009

  Prepared a product dossier for new product and renewal product registrations; Control and Review for standard operational improvement. Prepared a product dossier for new product and renewal product registrations; Control and Review for standard operational improvement.