Regulatory Document Coordinator
2 days ago
Role and Responsibilities:
The Regulatory Affairs Associate will report to the Head of Regulatory Affairs and will be responsible for ensuring regulatory compliance and meeting local regulatory milestones within our portfolios in Malaysia and Brunei.
Key Performance Indicators:
- Regulatory Submissions: Timely submission of regulatory applications for product approvals, license renewals, and labeling changes.
- Documentation and Compliance: Accuracy and completeness of regulatory documentation, including product registrations, promotional materials, and labeling changes.
- Regulatory Tracking: Maintenance and update of internal regulatory tracking systems to ensure timely completion of regulatory milestones and submissions.
- Communication: Effective communication with regulatory agencies, stakeholders, and other departments to provide status updates on submissions and to respond to inquiries or requests for additional information.
Requirements:
- Education: Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
- Experience: Minimum of 1 year of experience in Regulatory Affairs, ideally in the pharmaceutical or consumer health industry. Strong understanding of local and international regulatory requirements and processes.
- Communication Skills: Excellent written and verbal communication skills for preparing documents, reports, and engaging with stakeholders.
- Attention to Detail: Strong attention to detail and accuracy in regulatory documentation and processes.
- Problem-Solving: Analytical and problem-solving skills for addressing regulatory issues and challenges.
- Time Management: Strong organizational skills with the ability to manage multiple tasks and meet deadlines.
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