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Regulatory Affairs Specialist

RM 4,000 - RM 5,000 / month

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Job Description

Job Purpose:
To support regulatory activities for pharmaceutical products, including developing and implementing regulatory strategies, reviewing, preparing, and managing regulatory submissions, and ensuring compliance with health authority requirements across various therapeutic areas.

Major Accountabilities:

Regulatory Strategy:

  • Prepare submission dossiers for post-approval variations within agreed timelines.
  • Stay updated on regulatory requirements.
  • Build and maintain strong relationships with internal and external stakeholders.
  • Support the identification and resolution of regulatory compliance gaps.
  • Perform regulatory assessments for variations.

Regulatory Operations Management:

  • Develop and maintain regulatory databases and files.
  • Ensure compliance with local regulations and company policies.
  • Prepare monthly reports and provide updates to stakeholders.
  • Gather and process information from stakeholders.
  • Provide administrative support as needed.

Collaboration with Cross-functional Teams:

  • Support process improvements and implement best practices.
  • Work with Supply Chain, Quality Assurance, and Patient Safety teams on quality and safety matters.
  • Collaborate with global regulatory teams as required.

Ideal Background:

  • Diploma in health-related or pharmaceutical sciences.
  • At least 1 year of experience in regulatory affairs or a related field.
  • Proven track record in preparing and managing regulatory applications.
  • Strong knowledge of pharmaceutical processes and local regulatory guidelines.
  • Proficient in MS Office and data management.
  • Strong interpersonal, organizational, negotiation, and problem-solving skills.
  • Excellent verbal and written communication skills.

Personal Attributes:

  • Self-starter with a hands-on approach and a “can-do” attitude.
  • Independent, results-oriented, and self-motivated.
  • Capable of defining, evaluating, and managing risks.
  • Strong organizational skills with a commercial mindset.
  • Adaptable, proactive, and solutions-focused.
  • High level of ethics, integrity, and professionalism.
  • Ability to thrive in a changing and uncertain environment.

Job Types: Full-time, Contract
Contract length: 12 months

Pay: RM4,000.00 - RM5,000.00 per month

Benefits:

  • Health insurance
  • Professional development

Schedule:

  • Monday to Friday

Work Location: In person