Regulatory Submission Expert
2 days ago
We are seeking a highly skilled Regulatory Submission Specialist to join our team. The ideal candidate will have extensive knowledge of EU Clinical Trial Applications and experience in regulatory document management.
Key Responsibilities:- Ensure technical compliance of clinical trial submissions via smooth information flow between all functional areas.
- Support assembly of submission packages and supportive documentation for regulatory deliverables.
- Operate the clinical trial submissions and notifications system, ensuring timely and accurate delivery.
- Coordinate clinical trial submissions and notifications through EMA CTIS, serving as a single point of contact for incoming notifications and alerts.
- Review and triage requests for information from health authorities, submitting clinical trial results to CTIS when necessary.
- Advanced technical and project management skills.
- Strong knowledge of EU Clinical Trial Applications and Veeva Vault RIM.
- Opportunity to work with a dynamic team on high-profile projects.
- Professional growth and development opportunities.
- Masters degree and 1-2 years of directly related experience.
- Bachelors degree and 2-3 years of directly related experience.
- Associates degree and 3-5 years of directly related experience.
- High school diploma/GED and 5+ years of directly related experience.
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Cmc regulatory expert
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Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
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Cmc Regulatory Expert
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Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team.This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities.The ideal candidate will have...
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CMC Regulatory Expert
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CMC Regulatory Expert
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CMC Regulatory Specialist
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