Regulatory Compliance Specialist
">
This role plays a pivotal part in upholding the integrity of clinical trials across global organizations. As a key member of our Medicines Quality Organisation (MQO), you will work closely with the team to ensure seamless execution.
Key Responsibilities:
1. Develop and review area-specific procedures, resource documents, and supplemental materials to maintain high-quality standards.
2. Recommend new quality system documents or changes to existing ones where applicable.
3. Provide expert guidance on training and documentation.
4. Offer consultation on the interpretation and practical application of external requirements, standards, and procedures.
5. Ensure accurate documentation, escalation, and completion of deviations, change controls, and Notification to Management (NTM).
6. Conduct root cause analysis and implement corrective/preventive actions (CAPA) as necessary.
7. Collaborate on risk assessments, audit planning, and/or quality plans based on identified risks/gaps.
8. Drive self-inspections and foster meaningful improvements.
9. Implement local quality systems as necessary.
10. Support external party management as assigned.
Requirements:
* Bachelor's Degree in a science/technology/healthcare-related field or equivalent experience.
* Proven ability to apply quality systems within a regulated environment.
* Experience in quality control/quality assurance roles.
* Background in functional business areas such as medical writing, regulatory affairs, or clinical trial management.
* Strong project and time management skills.
* Effective communication and interpersonal skills.
* Able to prioritize and manage multiple concurrent tasks.
* Flexibility in varying environments/geographies.
* Strong organization/self-management skills.
* Ability to work independently and as part of a team.