About the job
At Precision for Medicine, we pride ourselves on being a pioneering force in the world of Contract Research Organizations (CRO). By merging cutting-edge technology with deep scientific expertise, we enhance the efficiency, cost-effectiveness, and success rates of delivering transformative therapies to patients. Our specialization lies in Oncology and Rare Diseases, where we leverage our extensive clinical trial execution capabilities alongside advanced laboratory and data science solutions.
We are currently seeking an experienced Regulatory Manager or Senior Regulatory Manager (depending on your expertise) to join our dynamic team. This role will be pivotal in providing strategic regulatory guidance and oversight throughout the clinical trial lifecycle.
As a Regulatory Manager, you will offer critical regulatory strategy and development guidance to ensure the optimal conduct of clinical trials, manage regulatory agency interactions, facilitate orphan designations, and oversee pediatric planning and accelerated procedures. Your role will be key in ensuring the timely preparation of high-quality regulatory submissions that comply with all relevant regulations.
Key Responsibilities Include:
- Deliver regulatory guidance throughout the entire clinical development lifecycle.
- Compile, coordinate, and review regulatory submissions to authorities, including CTA/IND applications, annual reports, routine amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications, while providing strategic regulatory insights as needed.
- Develop and review documentation for submission to Regulatory Authorities and/or Ethics Committees, ensuring adherence to regulatory standards.