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REGULATORY AFFAIRS EXECUTIVE

Job title: REGULATORY AFFAIRS EXECUTIVE
Contract type: Permanent
Location: Kedah
Specialisation:
Salary: RM6,500 - RM7,000
Start date: 28-09-2021
Reference: PR/145312
Contact details: Jing May How
Contact email: jingmay.how@jac-recruitment.com
Job published: August 23, 2021 11:15

JOB RESPONSIBILITIES

  • Liaise with the local Health Authority on matters pertaining to regulatory activities, licenses and permits for new and existing products.
  • Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes.
  • Review technical dossier of new products and prepare additional documents where necessary.
  • In-charge with the timely approval and renewal of product licences, company licenses, pre- and post-approval variations, permits and other applications.
  • Provide appropriate solutions for compliance issues.
  • Review and approve advertising and promotional items to ensure regulatory compliance.
  • Build and maintain relationships with key regulatory officials to influence regulators to achieve positive outcomes for product approvals or industry advantages.
  • Keep updated with local Health Authority regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties.
  • Maintain a current awareness of the regulatory requirements for the marketing of medicinal products in Malaysia and general legislation and guidelines.

JOB REQUIREMENTS

  • Degree qualification in life science related fields.
  • Minimum 3 years’ experience in Regulatory Affairs, particularly in drug or medical device. Experienced in registering cosmetic, food supplement or chinese medicine will be added advantage.
  • Ability to maintain confidentiality of sensitive areas.
  • Ability to work independently, good communication and interpersonal skills.
  • Excellent verbal and written communication skills in English & Malay.
  • Territory: Singapore & Malaysia