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Há 5 dias
Senior Regulatory Documentation Specialist
\About the Role:\We are seeking a highly skilled Senior Regulatory Specialist to ensure compliance with regulatory requirements and maintain accurate documentation. The ideal candidate will have primary contact with investigative sites during site start-up activities and maintenance, collecting investigator and essential documents for studies.
\Main Responsibilities:\- Ensure compliance with regulatory requirements;
- Maintain investigator and essential documents for studies;
- Closely work with project management and Site Readiness team to ensure documentation meets specifications required by sponsors and applicable regulations;
- Coordinate local applications and submissions as necessary;
- Monitor and report on progress and any issues arising.
- 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.
- 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.
This role requires strong analytical and problem-solving skills, along with excellent communication and time management skills. If you are a detail-oriented professional with a passion for regulatory compliance, we encourage you to apply.
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