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Role Overview:
- Provide regulatory strategy and development guidance for optimal conduct of clinical trials.
- Coordinate and prepare regulatory submissions to authorities and ethics committees.
Key Responsibilities:
- Offer regulatory guidance throughout the clinical development lifecycle.
- Serve as representative of Global Regulatory Affairs at project team and business development meetings.
- Oversee Regulatory Affairs Specialists and maintain project plans and trackers.
Qualifications:
- Bachelor's degree or equivalent in a scientific or healthcare discipline.
- 5+ years regulatory experience for Manager, 7+ for Senior Manager.
- Knowledge of drug development process and regulatory activities in EU/US.
Additional Requirements:
- Strong interpersonal skills and ability to manage multiple tasks.
- Availability for domestic and international travel.
Precision for Medicine
Precision for Medicine is a CRO that integrates clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences, focusing on Oncology and Rare Disease. They are a growing global team that values employee contributions and fosters an environment where ideas are valued and nurtured.