Regulatory Affairs Specialist
hace 2 días
As a Regulatory Coordinator at Alimentiv Inc., you will play a vital role in ensuring the compliance of clinical trials with regulatory requirements. Your primary responsibility will be to assist with and/or complete submissions to Regulatory Authorities, Ethics Committees, and other review bodies.
Key Responsibilities- Submit documents related to clinical trials to relevant authorities
- Maintain accurate records of submissions and subsequent activities
- Collaborate with senior team members to mitigate regulatory risks
- Develop and author country-specific Informed Consent Forms
- Obtain translations for local language documents
In this role, you will have the opportunity to work on various aspects of clinical trial management, including submission support and document tracking. If you are detail-oriented and possess excellent communication skills, we encourage you to apply for this position.
Requirements- Post-secondary certificate + 1-3 years of related experience
- Life sciences specialty or Regulatory designation preferred
- Attention to detail and ability to work independently
- Familiarity with ICH-GCP and regional regulations
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