Regulatory Manager Senior Regulatory Manager
Role Overview
This role involves providing regulatory strategy and development guidance for clinical trials, including preparing submissions to Regulatory Authorities and Ethics Committees. As a Regulatory Manager or Senior Regulatory Manager, the position focuses on ensuring compliance with regulations and supporting the clinical development life cycle. The hire will impact the speed and success of bringing therapies to patients by coordinating regulatory documents and facilitating agency meetings.
Perks & Benefits
The job is fully remote in the United Kingdom, offering flexibility in work location. While time zone expectations are not specified, remote roles often require alignment with UK business hours. Career growth is implied through the seniority options, and the company culture emphasizes integration of scientific knowledge and advanced data sciences in a non-typical CRO environment.
Full Job Description
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
Precision for Medicine are recruiting a Regulatory Manager / Senior Regulatory Manager (depending on experience) to join our team.
The Regulatory Manager provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The Regulatory Manager coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable.
Essential functions of the job include but are not limited to:
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annPlease mention the word **EASES** and tag RODguMTk4Ljk5LjE0Mw== when applying to show you read the job post completely (#RODguMTk4Ljk5LjE0Mw==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.
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