JobHouse Ads Published on: 26/02/2015 | Closing date: 30/06/2015

Technical & Regulatory Senior Executive

Petaling Jaya, Selangor

Responsibilities:

  • Responsible to collate full documentation for registration and proceed with product registration to Ministry of Health of the confirmed products in compliance to The Control of Drugs and Cosmetics Regulations 1984
  • Responsible to collate full documentation for registration and proceed with product registration to Health Science Authority Singapore of the confirmed products
  • Responsible to collate full documentation for registration and proceed with product registration to Ministry of Health Brunei of the confirmed products
  • Responsible to collate full documentation for registration and proceed with product registration to Ministry of Health of the confirmed products in compliance to the Medical Devices Regulation in Malaysia, Singapore & Brunei
  • Advise Business Development and product Marketers on technical specification/ regulation requirements prior to any development/ R & D
  • Responsible to review new formulation and product information for product classification to ensure compliance to related regulations
  • Responsible to do periodic product audits to ensure all labeling and packaging of Amway’s products are fully complying to the local law and regulations at the point of sale i.e. products in the trade
  • Responsible to review artworks and prepare documentation for submission of brochure’s advertisement for the advertisement of regulated products with medical claims, and acts as liaison officer with Medicine Advertising Board (MAB) for approval of these advertisements, compliance to Medicines (Advertisement & Sale) Act 1956 (Revised 1983), The Medicine Advertisements Board Regulations 1976 and Cosmetics Advertisement Code
  • Responsible to compile and maintain systematic filling of PIF (Product Information File) for all cosmetic products as per Asian Cosmetic Directive requirements and registration dossier for all the related registered confirmed products
  • Responsible to review on all brochure and printed advertisement material to ensure compliance to regulatory requirements
  • Singapore regulatory maintenance and certification application support for related ASPL products
  • Liaison personnel with Amway head office (ABG and ADA on matters pertaining to the regulatory and technical issues

Requirements:

  • Tertiary education in Science, preferably in Chemistry, Bio-Chemistry or Pharmacy
  • Minimum 5 years working experience in the technical & regulatory area is preferred but not essential
  • Mature (above 30 years old), with a pleasant personality and good interpersonal skills
  • Able to establish a good rapport with Government agencies
  • Familiarity with submission procedures to local authorities would be an added advantage
  • Abreast in on regulations which related to product and business operations such as:
  • Malaysia Direct Selling Act and Regulations
  • Malaysia Control of Drugs and Cosmetics Regulations 1984
  • Malaysia Food Act and Regulations
  • Malaysia Trade Description Act
  • Malaysia/ Singapore/ Brunei Medical Device Regulations
  • Singapore Cosmetics Regulations
  • Singapore Health Supplement Guidelines
  • Malaysia Medicine Advertisements Board Regulations 1976
  • Relevant manufacturing regulation such as GMP for Health Supplement, GMP for Cosmetics, HACCP, Halal Guidelines
  • Regulations for wholesale and warehouse i.e. Good Distribution Practice & Good Storage Practice
  • Facility and documentation auditing skills
  • Requires someone who  actively participates in association initiatives and other relevant key external stakeholders to stay updated on  regulatory matters
  • Min 5 years regulatory experience with age 30 & above

Remuneration

Salary offered up to RM5,700.00