Study Start Up & Regulatory Manager - Italy Job type: Permanent Location: Milan, Italy Salary: Flexible for the right candidate Reference Number: J23348 Want to be a Subject Matter Expert within SSU & Regulatory Matters? Does your experience encompass developing strategy for global clinical trial submissions? Are you looking to progress to Manager level and act as CTA Lead for global submissions? My client is a full- service clinical research organisation, providing the full range of Phase I-IV clinical development services for the world's pharmaceutical, biotech and medical device industries. This organisation has business that spans across six continents, and are looking to strengthen their Ethics and regulatory department in the UK.
Job Description: As a member of the Study Start Up team you will cover a wide variety of therapeutic areas and phases. - Work within various areas of site start-up such as site activation, regulatory, submissions, site contracts or regulatory records - Client facing- ensuring customer/client requirements are met - Leading projects regarding clinical trial submissions to CA, LEC and CEC - Business development- involvement in bid defences - Act as the Subject Matter Expert in SSU & Regulatory functions
Job Requirements: - At least 6-7 years"e; experience in SSU/ Clinical Regulatory - Ethics Committee submission experience in multiple countries - Regulatory Authorities submission experience in multiple countries - Site Contracts oversight experience - Ideally line Management experience
Remember if this role is not suitable for you or you are no longer looking for a new job please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice. Key words: Regulatory, Regulatory Affairs, SSU, Study Start Up, Manager, Regulatory Affairs Manager, Clinical, CTA, Ethics Committee, Milan, Italy, home working, Competent Authorities, Site Activation