Senior Regulatory Documentation Specialist
4 semanas atrás
Job Overview
As a Senior Regulatory Specialist, you will be responsible for ensuring that all regulatory requirements are met and that documentation is compliant with applicable regulations.
The successful candidate will have primary contact with investigative sites during site start-up activities and maintenance. Your responsibilities will include the collection of investigator and essential documents for studies, ensuring that EC/IRB/Third body/Regulatory Authority and any other local applications are made within agreed timelines.
You will work closely with project management and the Site Readiness team to ensure that documentation meets specifications required by sponsor and applicable regulations.
Key Responsibilities:
- Ensure compliance with regulatory requirements;
- Collect and maintain investigator and essential documents for studies;
- Maintain effective communication with project management and Site Readiness team;
- Co-ordinate local applications and submissions as necessary;
- Monitor and report on progress and any issues arising.
Requirements:
- Degree in Life Sciences or related field;
- Strong understanding of regulatory requirements;
- Excellent communication and organisational skills;
- Ability to work independently and as part of a team;
- Proficient in Microsoft Office and electronic document management systems.
Preferred Qualifications:
- Relevant experience in regulatory affairs or clinical research;
- Familiarity with relevant legislation and regulations;
- Fluency in English and/or Portuguese;
- Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
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