About the job
At Precision for Medicine, we redefine the role of a Contract Research Organization (CRO) by combining cutting-edge technology with unparalleled expertise to enhance the efficiency, cost-effectiveness, and success rates of clinical trials aimed at delivering transformative therapies to patients. Our distinct approach integrates clinical trial execution with profound scientific knowledge, laboratory proficiency, and advanced data analytics, with a particular emphasis on Oncology and Rare Diseases.
We are seeking a Regulatory Manager or Senior Regulatory Manager (commensurate with experience) to join our dynamic team.
In this pivotal role, the Regulatory Manager will provide strategic regulatory guidance throughout the clinical trial lifecycle, facilitating regulatory agency meetings, orphan drug designations, pediatric planning, and expediting procedures. The role will ensure the timely preparation of organized, high-quality regulatory submissions, adhering to applicable regulations. Responsibilities include coordinating and preparing regulatory documents for submission to Regulatory Authorities and/or Ethics Committees as necessary.
Key responsibilities include, but are not limited to:
- Providing regulatory strategy and guidance throughout the clinical development lifecycle.
- Compiling, coordinating, and reviewing applications to Regulatory Authorities, including CTA/IND, annual reports, routine amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications, while offering strategic regulatory input as required.
- Developing and/or reviewing documents for submission to ensure compliance with regulatory standards.

