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Regulatory Affairs Project Manager

3 weeks ago

Klang, Selangor, Malaysia Monroe Consulting Group Full time

Monroe Consulting Group Malaysia is seeking an ambitious and experienced professional to join a leading provider of pharmaceutical services globally as a Regulatory Affairs Project Manager (SEA). The successful candidate will be responsible for ensuring the organisation meets its regulatory compliance requirements for new product registrations and variations to existing registrations within assigned portfolio and territories.

Key Responsibilities:
  • Prepare regulatory submissions for both new registrations and existing products in a cost-efficient and timely manner, minimising delays or interruptions to market supply.
  • Ensure regulatory submissions comply with relevant local legislation, regulations, and corporate requirements.
  • Collaborate with internal and external stakeholders to prepare and submit regulatory documents.
  • Analyse data packages to ensure compliance with agency legislation and guidelines prior to submission.

Requirements:

  • 5+ years' experience in Regulatory Affairs within the pharmaceutical industry.
  • Demonstrated experience in a regulatory role.
  • Bachelor's Degree/Master's in Medical Science/Pharmacy/Biotechnology or any relevant medical field.
  • Working knowledge and experience in Health Sciences Authority (HSA) and National Pharmaceutical Regulatory Agency (NPRA).