AL Solutions have partnered with a small CRO specializing in Oncology and Rare Disease studies, they have a global presence and are looking to Support their existing Regulatory affairs department with Freelance Senior Regulatory Affairs Associate.
Offering remote working from UK, France, Spain, Hungary, Italy & Germany. Looking for a freelancer to assist them until at least February.
- Leading Regulatory activities for complex global & early phase clinical trials
- Prepare, review and submit clinical trial applications to Regulatory Authorities, Ethics Committees across the global
- Aid with producing investigator brochures, protocols, IMPDs and other reg documents
- In charge of patient information documents
- Actively working with project managers helping monthly financial reports on project
- Assisting with development of fellow colleagues through mentoring and training
- Performing duties developing & writing SOP’s and helping with business development activities
- Bachelors Degree within Science or Medical field
- In depth knowledge of submitting clinical trials applications across different countries
- Experience with EU directive and National requirements for clinical trials
- Previously performed project reporting, Liaising with multiple stakeholders including clients and international operational teams
- Analytical, planning, investigative minded and strong problem solving skills
AL Solutions are a niche Life Science recruitment consultancy. We place professionals across the UK/EU for a variety of biotechnology, pharmaceutical and CRO companies ranging from small start-ups to large global organisations.