Regulatory Executive

Location: Kuala Lumpur

Salary up to RM 4,000.00

Job Description & Responsibilities

  • Prepare, review, and submit dossiers to regulatory authorities for registration of pharmaceutical products and medical devices.
  • Monitor product registration status; product renewal, license application and renewal, variation submission.
  • Attend to queries posted by regulatory authorities in timely manner.
  • Ensure company’s products comply with regulatory requirements.
  • Review labelling and marketing materials to ensure compliance with relevant regulatory requirements.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.           
  • Attend to Post-Market Surveillance Activities/ Request from regulatory authorities.

Requirements

  • Bachelor’s Degree in Science related field e.g. BioTechnology, Chemistry, Science & Technology, Biology, Pharmacology or equivalent.
  • Proficiency in English, Bahasa Malaysia.
  • 2-3 years experience in regulatory affairs within a pharmaceutical/healthcare company.
  • Able to work independently & goal driven.
  • Well organized, positive working attitudes, teamwork spirit, self-discipline and great attention to detail.

Interested candidates kindly send your updated CV to info@sixdegreeconsulting.com.

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