Clash
of Jobs
This feature is not ready yet
Sign up for the newsletter to get notified when it's available
Precision for Medicine is seeking a Regulatory Manager to join their team. This role can be based remotely in the UK, Spain, Hungary, Slovakia, Serbia, Romania, or Poland. The Regulatory Manager will provide regulatory strategy and development guidance for clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures. They will ensure timely preparation of quality regulatory submissions.
The role involves:
- Providing regulatory guidance throughout the clinical development life cycle
- Compiling and coordinating applications to Regulatory Authorities
- Developing and reviewing documents for submission to Regulatory Authorities and Ethics Committees
- Serving as a representative of Global Regulatory Affairs at project team meetings
- Overseeing and coordinating Regulatory Affairs Specialists
- Maintaining project plans and regulatory intelligence tools
- Assisting in the development of Regulatory Affairs Specialists
- Providing input into regulatory strategy and timeline development
- Assisting in establishing company standards
- Participating in corporate quality initiatives
- Keeping abreast of laws, regulations, and guidelines
- Providing ICH GCP guidance, advice, and training
- Serving as a representative of Global Regulatory Affairs at business development meetings
Requirements include:
- Bachelor's degree in a scientific or healthcare discipline
- 5-7 years of regulatory experience (depending on the level)
- Computer literacy (MS Office/ Office 365)
- Fluency in English
- Regulatory affairs experience working for a Clinical Research Organisation
- Experience leading Clinical Submissions
- Informed knowledge of all aspects of the drug development process
- Knowledgeable of clinical trials methodology
- Knowledge and expertise with relevant regulations and guidance
- Availability for domestic and international travel
Precision for Medicine offers:
- Opportunity to work on ground breaking cancer therapies
- Valued input and ideas
- Positive impact on the company
Precision for Medicine
Precision for Medicine is dedicated to enhancing clinical research and development. They achieve this by providing specialized services that integrate scientific understanding with advanced analytical platforms. They help optimize clinical trials, accelerate drug development, and enable a deeper understanding of disease mechanisms, ultimately aiming to improve patient outcomes through precision medicine approaches and tailored therapeutics.