About the job
At Precision for Medicine, we redefine the role of a Clinical Research Organization (CRO) by integrating innovative technologies and unparalleled expertise to enhance the life sciences sector. Our mission is to accelerate the development of transformative therapies, particularly focusing on Oncology and Rare Diseases. We combine clinical trial execution with profound scientific insight, laboratory proficiency, and advanced data analytics to optimize outcomes.
We are currently seeking a skilled Regulatory Manager / Senior Regulatory Manager (commensurate with experience) to join our dynamic team. In this pivotal role, you will spearhead regulatory strategy and development initiatives that ensure the efficient conduct of clinical trials, regulatory agency consultations, orphan designations, pediatric planning, and expedited procedures. You will be responsible for the timely and organized preparation of high-quality regulatory submissions in accordance with applicable regulations.
Key responsibilities include but are not limited to:
- Providing comprehensive regulatory guidance across the entire clinical development lifecycle.
- Compiling, coordinating, and reviewing submissions to Regulatory Authorities, including CTA/IND applications, annual reports, amendments, scientific advice meetings, orphan designations, pediatric planning, and marketing applications, while offering strategic regulatory insights as needed.
- Developing and/or reviewing documents intended for submission to Regulatory Authorities and/or Ethics Committees to ensure adherence to regulatory standards.

