Regulatory Compliance Officer
hace 5 días
The Regulatory Coordinator is responsible for ensuring the compliance of clinical trials with regulatory requirements. This involves working closely with the internal study team, sponsor, and external stakeholders to ensure timely and accurate submissions.
Main Responsibilities- Develop and maintain study regulatory trackers
- Author Submission Management Plans and Translation Requirements Plans
- Prepare response submissions to information requests
- Maintain accurate records of submissions and subsequent activities
This role requires strong communication and organizational skills, as well as the ability to work effectively in a team environment. If you are a motivated individual with a passion for regulatory affairs, we encourage you to apply for this position.
Qualifications- Minimum post-secondary certificate + 1-3 years of related experience
- Basic understanding of ICH-GCP and regional regulations
- Resourceful and able to source regulatory requirements
- Proficient in Microsoft-based systems: Word, Excel, PowerPoint
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