Regulatory Affairs Executive

Kuala Lumpur, Malaysia

Job Description

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

s:
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 labeling 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.

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Job Detail

  • Job Id
    JD864761
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    3000 per month
  • Employment Status
    Permanent
  • Job Location
    Kuala Lumpur, Malaysia
  • Education
    Not mentioned