Regulatory Specialist
2 semanas atrás
As a key member of our organization, you will play a crucial role in ensuring compliance with regulatory standards and guidelines. This position requires strong communication skills, attention to detail, and the ability to work effectively in a team environment.
Key Responsibilities:
- Maintain awareness of current regulatory standards and guidelines related to clinical research.
- Coordinate the collection and organization of documents required for regulatory submissions.
- Prepare and review submission documents to ensure accuracy and compliance.
- Liaise with internal and external stakeholders to resolve issues and provide guidance on regulatory requirements.
- Ensure that all assigned start-up and maintenance activities are completed in accordance with client expectations and regulatory requirements.
Requirements:
- University/College degree in a life science or related field, or equivalent experience.
- Minimum 3 years of experience in clinical development or start-up/regulatory process.
- Working knowledge of ICH, RA, IRB/IEC, and other applicable regulations/guidelines.
Benefits:
- Opportunity to work in a dynamic and growing organization.
- Chance to develop your skills and expertise in regulatory affairs.
- Collaborative and supportive work environment.
How to Apply:
To be considered for this exciting opportunity, please submit your application with your resume and cover letter.
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