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Clinical Trial Regulatory Expert
hace 2 semanas
Job Description:
As a Regulatory Manager at Precision for Medicine, you will play a critical role in ensuring the success of our clinical trials by providing regulatory strategy and development guidance.
Key Responsibilities:
- Provide regulatory input on clinical trial protocols and amendments.
- Develop and review regulatory documents, including IND/CTA submissions.
- Coordinate and prepare regulatory submissions to ensure timely preparation and compliance.
- Represent Global Regulatory Affairs at project team meetings.
Qualifications:
- Bachelor's degree or equivalent experience in a scientific or healthcare discipline.
- 5 years of regulatory experience required for the Manager level and 7 years for the Senior Manager Regulatory level.
- Knowledge of ICH GCP guidelines and regulations.
- Excellent communication and interpersonal skills.
About Precision for Medicine:
We are a precision medicine Clinical Research Organization that leverages advanced technologies and expertise to deliver innovative clinical trials solutions.
