
Regulatory Compliance Specialist
3 days ago
Job Title: Regulatory Compliance Specialist
The Regulatory Compliance Specialist plays a critical role in supporting policy initiatives relevant to medicines within the Medicines Approvals and Regulation Unit. This involves preparing briefing documents, work instructions, fact sheets, guidance documents, submissions, correspondence, and reports.
About this Role
- Prepare and review documentation for policy projects;
- Contribute to the development of regulatory processes and procedures;
- Provide advice and guidance to team members on regulatory matters;
- Monitor outstanding approval and licensing requests, and initiate remedial actions as needed;
- Support the overall effective functioning of the unit through administrative duties and collaboration with team members.
Key Responsibilities
- Develop and maintain accurate records of regulatory activities;
- Assist in the preparation of submissions and reports;
- Liaise with stakeholders to ensure compliance with regulatory requirements;
- Analyze data to identify trends and areas for improvement;
- Recommend changes to improve regulatory processes.
Skills and Qualifications
- Highly developed interpersonal, consultation, and communication skills;
- Able to effectively interact with senior management, team members, and external stakeholders;
- Strong analytical and problem-solving skills;
- Ability to work independently and collaboratively as part of a team;
- Flexible approach to work and willingness to participate in initiatives to address critical issues.
Benefits
This role offers the opportunity to work in a dynamic environment, contributing to the success of the Medicines Approvals and Regulation Unit. You will have the chance to develop your skills and expertise, working with a team of dedicated professionals who are passionate about making a difference in public health.
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